No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 50601557110966 | 11-2002 | 11-2002 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form geneX®; a hard but resorbable matrix. | MQV | Filler, Bone Void, Calcium Compound | 2 | geneX® ds |
2 | 50601557110898 | 11-2005 | 11-2005 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form geneX®; a hard but resorbable matrix. | MQV | Filler, Bone Void, Calcium Compound | 2 | geneX® ds |
3 | 50601557109526 | 980-002 | 980-002 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe.When injected the mixture sets to form geneX®; a hard but resorbable matrix. | MQV | Filler, Bone Void, Calcium Compound | 2 | geneX® ds |
4 | 50601557105016 | 160-935ST | 160-935ST | The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an a The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok® ST Screw is for use as a fixation screw in cruciate ligament surgery. It provides a combination of suspension and compression fixation that resorbs and it is subsequently replaced with bone during the healing process. Bilok® ST Screw is biodegradable and biocompatible. | HWC | Screw, Fixation, Bone | 2 | Bilok® ST Screw |
5 | 50601557104958 | 160-930ST | 160-930ST | The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an a The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok® ST Screw is for use as a fixation screw in cruciate ligament surgery. It provides a combination of suspension and compression fixation that resorbs and it is subsequently replaced with bone during the healing process. Bilok® ST Screw is biodegradable and biocompatible. | HWC | Screw, Fixation, Bone | 2 | Bilok® ST Screw |
6 | 15060155710966 | 980-005 | 980-005 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe.When injected the mixture sets to form geneX®; a hard but resorbable matrix. | MQV | Filler, Bone Void, Calcium Compound | 2 | geneX® ds |
7 | 15060155710959 | 980-002 | 980-002 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe.When injected the mixture sets to form geneX®; a hard but resorbable matrix. | MQV | Filler, Bone Void, Calcium Compound | 2 | geneX® ds |
8 | 15060155710508 | 160-935ST | 160-935ST | The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an a The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok® ST Screw is for use as a fixation screw in cruciate ligament surgery. It provides a combination of suspension and compression fixation that resorbs and it is subsequently replaced with bone during the healing process. Bilok® ST Screw is biodegradable and biocompatible. | HWC | Screw, Fixation, Bone | 2 | Bilok® ST Screw |
9 | 15060155710492 | 160-930ST | 160-930ST | The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an a The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok® ST Screw is for use as a fixation screw in cruciate ligament surgery. It provides a combination of suspension and compression fixation that resorbs and it is subsequently replaced with bone during the healing process. Bilok® ST Screw is biodegradable and biocompatible. | HWC | Screw, Fixation, Bone | 2 | Bilok® ST Screw |
10 | 50601557101506 | 900-010 | 900-010 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form geneX® a hard but resorbable matrix. geneX® is supplied sterile | MQV | Filler, Bone Void, Calcium Compound | 2 | geneX® |
11 | 50601557101438 | 900-005 | 900-005 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form geneX® a hard but resorbable matrix. geneX® is supplied sterile | MQV | Filler, Bone Void, Calcium Compound | 2 | geneX® |
12 | 50601557100998 | 600-30-s1 | 600-30-s1 | Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for sing Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Dispenser |
13 | 15060155710157 | 900-010 | 900-010 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form geneX® a hard but resorbable matrix. geneX® is supplied sterile | MQV | Filler, Bone Void, Calcium Compound | 2 | geneX® |
14 | 15060155710140 | 900-005 | 900-005 | geneX® is a simple to use synthetic resorbable material designed to promote rege geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form geneX® a hard but resorbable matrix. geneX® is supplied sterile | MQV | Filler, Bone Void, Calcium Compound | 2 | geneX® |
15 | 15060155710096 | 600-30-s1 | 600-30-s1 | Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for sing Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Dispenser |
16 | 50601557114230 | Genex® Bone Graft Substitute 10cc | 910-010 | Genex® Bone Graft Substitute is a simple to use synthetic resorbable material de Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form Genex® Bone Graft Substitute a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile. | MQV | Filler, Bone Void, Calcium Compound | 2 | Genex® |
17 | 50601557114162 | Genex® Bone Graft Substitute 5cc | 910-005 | Genex® Bone Graft Substitute is a simple to use synthetic resorbable material de Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form Genex® Bone Graft Substiute, a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile. | MQV | Filler, Bone Void, Calcium Compound | 2 | Genex® |
18 | 50601557113318 | 660-001 | 660-001 | The STIMULAN® Bullet Mat and Introducer is a surgical instrument whcih includes The STIMULAN® Bullet Mat and Introducer is a surgical instrument whcih includes a mat for preparation of the STIMULAN® bullets, a 7mm introducer, a 9mm introducer and an obturator for hard to reach defects. To be used with 20cc Stimulan Rapid Cure | LXH | Orthopedic Manual Surgical Instrument | 1 | Stimulan Bullet Mat & Introducer |
19 | 50601557110416 | 620-020 | 620-020 | STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cu STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set insitu or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate(CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Rapid Cure |
20 | 50601557110348 | 620-010 | 620-010 | STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cu STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set insitu or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate(CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Rapid Cure |
21 | 50601557110270 | 620-005 | 620-005 | STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cu STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set insitu or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate(CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Rapid Cure |
22 | 15060155711413 | 910-005 | 910-005 | Genex® Bone Graft Substitute is a simple to use synthetic resorbable material de Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form Genex® Bone Graft Substiute, a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile. | MQV | Filler, Bone Void, Calcium Compound | 2 | Genex® |
23 | 50601557101742 | 920-005 | 920-005 | geneX® putty consists of an inorganic framework of calcium based ions. geneX® Pu geneX® putty consists of an inorganic framework of calcium based ions. geneX® Putty has been bioengineered to mimic human bone. It is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. geneX® Putty is a non-setting putty and is supplied sterile. | MQV | Filler, Bone Void, Calcium Compound | 2 | geneX® Putty |
24 | 15060155711338 | 660-001 | 660-001 | The STIMULAN® Bullet Mat and Introducer is a surgical instrument whcih includes The STIMULAN® Bullet Mat and Introducer is a surgical instrument whcih includes a mat for preparation of the STIMULAN® bullets, a 7mm introducer, a 9mm introducer and an obturator for hard to reach defects. To be used with 20cc Stimulan Rapid Cure | LXH | Orthopedic Manual Surgical Instrument | 1 | Stimulan Bullet Mat & Introducer |
25 | 15060155711451 | 620-003 | 620-003 | STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cu STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set insitu or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate(CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Rapid Cure |
26 | 15060155711420 | 910-010 | 910-010 | Genex® Bone Graft Substitute is a simple to use synthetic resorbable material de Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form Genex® Bone Graft Substitute a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile. | MQV | Filler, Bone Void, Calcium Compound | 2 | Genex® |
27 | 15060155711048 | 620-020 | 620-020 | STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cu STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set insitu or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate(CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Rapid Cure |
28 | 15060155711031 | 620-010 | 620-010 | STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cu STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set insitu or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate(CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Rapid Cure |
29 | 15060155711024 | 620-005 | 620-005 | STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cu STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set insitu or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate(CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Rapid Cure |
30 | 15060155710171 | 920-005 | 920-005 | geneX® putty consists of an inorganic framework of calcium based ions. geneX® Pu geneX® putty consists of an inorganic framework of calcium based ions. geneX® Putty has been bioengineered to mimic human bone. It is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. geneX® Putty is a non-setting putty and is supplied sterile. | MQV | Filler, Bone Void, Calcium Compound | 2 | geneX® Putty |
31 | 15060155711499 | 910-010Z | 910-010Z | genex® Bone Graft Substitute is a simple to use synthetic absorbable material de genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder filled syringe and mixing solution which, when combined, provides a mouldablecohesive paste which may be implanted into open voids/gaps of the musculoskeletal system to set insitu or placed in the bead mould mat provided to form beads for implantation. When injected the mixturesets to form genex® Bone Graft substitute a hard but absorbable matrix. genex® Bone Graft Substituteis supplied sterile. genex® Bone Graft Substitute , accessories and packaging are not made from natural rubber latex.genex® Bone Graft Substitute is MR safe. | MQV | Filler, Bone Void, Calcium Compound | 2 | Genex Bone Graft Substitute |
32 | 15060155711482 | 910-005Z | 910-005Z | genex® Bone Graft Substitute is a simple to use synthetic absorbable material de genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder filled syringe and mixing solution which, when combined, provides a mouldablecohesive paste which may be implanted into open voids/gaps of the musculoskeletal system to set insitu or placed in the bead mould mat provided to form beads for implantation. When injected the mixturesets to form genex® Bone Graft substitute a hard but absorbable matrix. genex® Bone Graft Substituteis supplied sterile. genex® Bone Graft Substitute , accessories and packaging are not made from natural rubber latex.genex® Bone Graft Substitute is MR safe. | MQV | Filler, Bone Void, Calcium Compound | 2 | Genex Bone Graft Substitute |
33 | 15060155711475 | 910-003Z | 910-003Z | genex® Bone Graft Substitute is a simple to use synthetic absorbable material de genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder filled syringe and mixing solution which, when combined, provides a mouldablecohesive paste which may be implanted into open voids/gaps of the musculoskeletal system to set in situ or placed in the bead mould mat provided to form beads for implantation. When injected the mixture sets to form genex® Bone Graft substitute a hard but absorbable matrix. genex® Bone Graft Substituteis supplied sterile. genex® Bone Graft Substitute , accessories and packaging are not made from natural rubber latex. genex® Bone Graft Substitute is MR safe. | MQV | Filler, Bone Void, Calcium Compound | 2 | Genex Bone Graft Substitute |
34 | 50601557100370 | 800-010 | 800-010 | Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process. | MQV | Filler, Bone Void, Calcium Compound | 2 | Allogran-R® |
35 | 50601557101292 | 600-010 | 600-010 | STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be injected or digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Kit is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Kit |
36 | 50601557101124 | 600-005 | 600-005 | STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be injected or digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Kit is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Kit |
37 | 50601557100448 | 800-020 | 800-020 | Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process. | MQV | Filler, Bone Void, Calcium Compound | 2 | Allogran-R® |
38 | 50601557100202 | 800-005 | 800-005 | Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process. | MQV | Filler, Bone Void, Calcium Compound | 2 | Allogran-R® |
39 | 15060155711215 | 3910-200-086 | 3910-200-086 | The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with polyethylene sutures. | HWC | Screw, Fixation, Bone | Biosteon® IntraLine® | |
40 | 15060155711208 | 3910-200-085 | 3910-200-085 | The Biosteon® IntraLine® 6.5mm HA/PLLA Needled Suture Anchor with two #2 Force F The Biosteon® IntraLine® 6.5mm HA/PLLA Needled Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with stainless steel needles and polyethylene sutures. | HWC | Screw, Fixation, Bone | 2 | Biosteon® IntraLine® |
41 | 15060155711192 | 3910-200-084 | 3910-200-084 | The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, i The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with polyethylene sutures. | HWC | Screw, Fixation, Bone | Biosteon® IntraLine® | |
42 | 15060155711185 | 3910-200-083 | 3910-200-083 | The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with polyethylene sutures. | HWC | Screw, Fixation, Bone | Biosteon® IntraLine® | |
43 | 15060155711178 | 3910-200-082 | 3910-200-082 | The Biosteon® IntraLine® 5.5mm HA/PLLA Needled Suture Anchor with two #2 Force F The Biosteon® IntraLine® 5.5mm HA/PLLA Needled Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with stainless steel needles and polyethylene sutures. | HWC | Screw, Fixation, Bone | Biosteon® IntraLine® | |
44 | 15060155711161 | 3910-200-081 | 3910-200-081 | The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, i The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with polyethylene sutures. | HWC | Screw, Fixation, Bone | 2 | Biosteon® IntraLine® |
45 | 15060155710126 | 600-010 | 600-010 | STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be injected or digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Kit is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Kit |
46 | 15060155710119 | 600-005 | 600-005 | STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be injected or digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Kit is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. | MQV | Filler, Bone Void, Calcium Compound | 2 | Stimulan® Kit |
47 | 15060155710034 | 800-010 | 800-010 | Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process. | MQV | Filler, Bone Void, Calcium Compound | 2 | Allogran-R® |
48 | 15060155710027 | 800-005 | 800-005 | Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process. | MQV | Filler, Bone Void, Calcium Compound | 2 | Allogran-R® |
49 | 50601557105498 | 160-725T | 160-725T | The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok° Screw provides an interference fixation during femoral and/or tibial fixation in ACL reconstruction that resorbs and is replaced with bone during the healing process. Bilok® Screws are biodegradable and biocompatible and should not be used at an infected site. | HWC | Screw, Fixation, Bone | 2 | Bilok® Screw |
50 | 50601557106556 | 160-135T | 160-135T | The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok° Screw provides an interference fixation during femoral and/or tibial fixation in ACL reconstruction that resorbs and is replaced with bone during the healing process. Bilok® Screws are biodegradable and biocompatible. | HWC | Screw, Fixation, Bone | 2 | Bilok® Screw |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00816986020518 | 200X25X8 MM, 40 CC | SGFS-040 | SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising b SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process. | SIGNAFUSE Bioactive Bone Graft | BIOVENTUS LLC |
2 | 00816986020501 | 100X25X8 MM, 20 CC | SGFS-020 | SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising b SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process. | SIGNAFUSE Bioactive Bone Graft | BIOVENTUS LLC |
3 | 00816986020495 | 50X25X8 MM, 10 CC | SGFS-010 | SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising b SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process. | SIGNAFUSE Bioactive Bone Graft | BIOVENTUS LLC |
4 | 00816986020488 | 25X25X8 MM, 5 CC | SGFS-005 | SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising b SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process. | SIGNAFUSE Bioactive Bone Graft | BIOVENTUS LLC |
5 | 00816986020150 | 15g | MSBG1500 | Bioactive Bone Graft Putty | UNITE Bioactive Bone Graft | BIOVENTUS LLC |
6 | 00816986020143 | 7.5g | MSBG0750 | Bioactive Bone Graft Putty | UNITE Bioactive Bone Graft | BIOVENTUS LLC |
7 | 00816986020136 | 3.75g | MSBG0375 | Bioactive Bone Graft Putty | UNITE Bioactive Bone Graft | BIOVENTUS LLC |
8 | 00816986020129 | 18cc | OMP-18 | OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules sus OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process. | OSTEOMATRIX+ | BIOVENTUS LLC |
9 | 00816986020112 | 9cc | OMP-09 | OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules sus OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process. | OSTEOMATRIX+ | BIOVENTUS LLC |
10 | 00816986020105 | 15g | OF003 | Bioactive Bone Graft Putty | OSTEOFUSE | BIOVENTUS LLC |
11 | 00816986020099 | 7.5g | OF002 | Bioactive Bone Graft Putty | OSTEOFUSE | BIOVENTUS LLC |
12 | 00816986020082 | 3.75g | OF001 | Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixtur Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules (CaP) and (45S5) bioactive glass granules suspended in a resorbable alkyleneoxide polymer (AOP) carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes. | OSTEOFUSE | BIOVENTUS LLC |
13 | 00816986020037 | IFBG100 | IFBG100 | INTERFACE is a synthetic bioactive bone graft for use in the repair of osseous d INTERFACE is a synthetic bioactive bone graft for use in the repair of osseous defects. It is supplied as irregular synthetic granules of bioactive glass (45S5 Bioglass), sized from 200 microns to 420 microns. When implanted in living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone mineral. The biological apatite layer of the granules provides an osteoconductive scaffold for the generation of new osseous tissue. New bone infiltrates around the granules allowing the repair of the defect as the granules are absorbed. | INTERFACE | BIOVENTUS LLC |
14 | 00816986020020 | 3.75g | SGF-037 | Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixtur Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules (CaP) and (45S5) bioactive glass granules suspended in a resorbable alkyleneoxide polymer (AOP) carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes. | SIGNAFUSE | BIOVENTUS LLC |
15 | 00816986020013 | 7.5g | SGF-075 | Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixtur Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules (CaP) and (45S5) bioactive glass granules suspended in a resorbable alkyleneoxide polymer (AOP) carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes. | SIGNAFUSE | BIOVENTUS LLC |
16 | 00816986020006 | 15g | SGF-150 | Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixtur Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules (CaP) and (45S5) bioactive glass granules suspended in a resorbable alkyleneoxide polymer (AOP) carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes. | SIGNAFUSE | BIOVENTUS LLC |
17 | 00816125022229 | RGT-50X25-05 | RGT-50X25-05 | R-GENIN is a bone void filler consisting of purified bovine collagen, hydroxyapa R-GENIN is a bone void filler consisting of purified bovine collagen, hydroxyapatite, tri-calcium phosphate, and demineralized bone matrix (DBM). The collagen component is biocompatible. After it is implanted, it resorbs and is later replaced by natural bone.R-GENIN is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous blood prior to use at the physician's discretion. | R-GENIN Strip | BERKELEY ADVANCED BIOMATERIALS, LLC |
18 | 00816125023868 | ARM-TCP-BA-12 | ARM-TCP-BA-12 | HA-TCP-Bioglass Sponge is a bone void filler consisting of a collagen matrix min HA-TCP-Bioglass Sponge is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.HA-TCP-Bioglass Sponge is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. HA-TCP-Bioglass Sponge must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. | HA-TCP-Bioglass Sponge | BERKELEY ADVANCED BIOMATERIALS, LLC |
19 | 00816125023851 | ARM-TCP-10 | ARM-TCP-10 | HA-TCP Sponge is a sterile bone graft composed of purified fibrillar Type I coll HA-TCP Sponge is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone.HA-TCP Sponge is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml. | HA-TCP Sponge | BERKELEY ADVANCED BIOMATERIALS, LLC |
20 | 00816125023844 | BF-10P | BF-10P | Bi-Ostetic Foam Putty is a sterile bone graft composed of purified fibrillar Typ Bi-Ostetic Foam Putty is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone.Bi-Ostetic Foam Putty is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml. | Bi-Ostetic Foam Putty | BERKELEY ADVANCED BIOMATERIALS, LLC |
21 | 00816125023837 | BF-05P | BF-05P | Bi-Ostetic Foam Putty is a sterile bone graft composed of purified fibrillar Typ Bi-Ostetic Foam Putty is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone.Bi-Ostetic Foam Putty is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml. | Bi-Ostetic Foam Putty | BERKELEY ADVANCED BIOMATERIALS, LLC |
22 | 00816125023820 | BF-02P | BF-02P | Bi-Ostetic Foam Putty is a sterile bone graft composed of purified fibrillar Typ Bi-Ostetic Foam Putty is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone.Bi-Ostetic Foam Putty is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml. | Bi-Ostetic Foam Putty | BERKELEY ADVANCED BIOMATERIALS, LLC |
23 | 00816125023813 | BF-01P | BF-01P | Bi-Ostetic Foam Putty is a sterile bone graft composed of purified fibrillar Typ Bi-Ostetic Foam Putty is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone.Bi-Ostetic Foam Putty is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml. | Bi-Ostetic Foam Putty | BERKELEY ADVANCED BIOMATERIALS, LLC |
24 | 00816125023806 | AA-10P | AA-10P | Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen m Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. | Bi-Ostetic Bioactive Glass Foam | BERKELEY ADVANCED BIOMATERIALS, LLC |
25 | 00816125023790 | AA-05P | AA-05P | Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen m Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. | Bi-Ostetic Bioactive Glass Foam | BERKELEY ADVANCED BIOMATERIALS, LLC |
26 | 00816125023783 | AA-01P | AA-01P | Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen m Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. | Bi-Ostetic Bioactive Glass Foam | BERKELEY ADVANCED BIOMATERIALS, LLC |
27 | 00816125023776 | C10 SWE12 | C10 SWE12 | Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone. | Tribio® DP Evans Wedge | BERKELEY ADVANCED BIOMATERIALS, LLC |
28 | 00816125023769 | C10 SWE10 | C10 SWE10 | Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone. | Tribio® DP Evans Wedge | BERKELEY ADVANCED BIOMATERIALS, LLC |
29 | 00816125023752 | C10 SWE08 | C10 SWE08 | Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone. | Tribio® DP Evans Wedge | BERKELEY ADVANCED BIOMATERIALS, LLC |
30 | 00816125023745 | C10 SWE06 | C10 SWE06 | Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone. | Tribio® DP Evans Wedge | BERKELEY ADVANCED BIOMATERIALS, LLC |
31 | 00816125023738 | C10 SWC08 | C10 SWC08 | Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone. | Tribio® DP Cotton Wedge | BERKELEY ADVANCED BIOMATERIALS, LLC |
32 | 00816125023721 | C10 SWC07 | C10 SWC07 | Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone. | Tribio® DP Cotton Wedge | BERKELEY ADVANCED BIOMATERIALS, LLC |
33 | 00816125023714 | C10 SWC06 | C10 SWC06 | Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone. | Tribio® DP Cotton Wedge | BERKELEY ADVANCED BIOMATERIALS, LLC |
34 | 00816125023707 | C10 SWC05 | C10 SWC05 | Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone. | Tribio® DP Cotton Wedge | BERKELEY ADVANCED BIOMATERIALS, LLC |
35 | 00816125023691 | AMWS-TCP-BA-12 | AMWS-TCP-BA-12 | HA-TCP-Bioglass Sponge is a bone void filler consisting of a collagen matrix min HA-TCP-Bioglass Sponge is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.HA-TCP-Bioglass Sponge is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. HA-TCP-Bioglass Sponge must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. | HA-TCP-Bioglass Sponge | BERKELEY ADVANCED BIOMATERIALS, LLC |
36 | 00816125023684 | AMWS-TCP-10 | AMWS-TCP-10 | HA-TCP Sponge is a sterile bone graft composed of purified fibrillar Type I coll HA-TCP Sponge is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone.HA-TCP Sponge is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml. | HA-TCP Sponge | BERKELEY ADVANCED BIOMATERIALS, LLC |
37 | 00816125023677 | OB-10D | OB-10D | OsteoBoost Select is a bio-engineered mixture of calcium-based inorganic compoun OsteoBoost Select is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, OsteoBoost Select resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.OsteoBoost Select is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs. | OsteoBoost Select 10cc | BERKELEY ADVANCED BIOMATERIALS, LLC |
38 | 00816125023660 | OB-05D | OB-05D | OsteoBoost Select is a bio-engineered mixture of calcium-based inorganic compoun OsteoBoost Select is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, OsteoBoost Select resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.OsteoBoost Select is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs. | OsteoBoost Select 5cc | BERKELEY ADVANCED BIOMATERIALS, LLC |
39 | 00816125023653 | M80 SB008 | M80 SB008 | Tribio™ Implant is a bone void filler consisting of a collagen matrix mineralize Tribio™ Implant is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible. The 45S5 glass particles are bioactive. The device is available in the form of granules, strips, and putty. The composition of the granules is 60 wt% HA and 40 wt% TCP. The amount of 45S5 granules in the graft is 20 wt%. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer on the 45S5 granules and hydroxyapatite-tri-calcium phosphate granules provide an osteoconductive scaffold onto which the patient’s new bone will grow. During healing, the graft particulate is absorbed and remodeled into new bone. | Tribio™ Implant, 7.5mm x 40mm | BERKELEY ADVANCED BIOMATERIALS, LLC |
40 | 00816125023646 | M80 SB006 | M80 SB006 | Tribio™ Implant is a bone void filler consisting of a collagen matrix mineralize Tribio™ Implant is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible. The 45S5 glass particles are bioactive. The device is available in the form of granules, strips, and putty. The composition of the granules is 60 wt% HA and 40 wt% TCP. The amount of 45S5 granules in the graft is 20 wt%. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer on the 45S5 granules and hydroxyapatite-tri-calcium phosphate granules provide an osteoconductive scaffold onto which the patient’s new bone will grow. During healing, the graft particulate is absorbed and remodeled into new bone. | Tribio™ Implant, 5.5mm x 40mm | BERKELEY ADVANCED BIOMATERIALS, LLC |
41 | 00816125023639 | AA1-100X25-12 | AA1-100X25-12 | Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen m Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. | Bi-Ostetic Bioactive Glass Foam | BERKELEY ADVANCED BIOMATERIALS, LLC |
42 | 00816125023622 | AA1-50X25-06 | AA1-50X25-06 | Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen m Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. | Bi-Ostetic Bioactive Glass Foam | BERKELEY ADVANCED BIOMATERIALS, LLC |
43 | 00816125023615 | 7888-0125 | 7888-0125 | OptiFuse BA is a bone void filler consisting of a collagen matrix mineralized wi OptiFuse BA is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.OptiFuse BA is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. OptiFuse BA must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. | OptiFuse BA 12.5cc Strip | BERKELEY ADVANCED BIOMATERIALS, LLC |
44 | 00816125023608 | 7888-0063 | 7888-0063 | OptiFuse BA is a bone void filler consisting of a collagen matrix mineralized wi OptiFuse BA is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.OptiFuse BA is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. OptiFuse BA must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. | OptiFuse BA 6.25cc Strip | BERKELEY ADVANCED BIOMATERIALS, LLC |
45 | 00816125023592 | BF1-100X25-05 | BF1-100X25-05 | Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Typ Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone.Bi-Ostetic Foam Strip is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml. | Bi-Ostetic Foam Strip | BERKELEY ADVANCED BIOMATERIALS, LLC |
46 | 00816125023585 | BF1-50X25-02 | BF1-50X25-02 | Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Typ Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone.Bi-Ostetic Foam Strip is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml. | Bi-Ostetic Foam Strip | BERKELEY ADVANCED BIOMATERIALS, LLC |
47 | 00816125023578 | AA1-100X25-15 | AA1-100X25-15 | Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen m Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. | Bi-Ostetic Bioactive Glass Foam | BERKELEY ADVANCED BIOMATERIALS, LLC |
48 | 00816125023561 | AA1-50X10-02 | AA1-50X10-02 | Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen m Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. | Bi-Ostetic Bioactive Glass Foam | BERKELEY ADVANCED BIOMATERIALS, LLC |
49 | 00816125023554 | C10 SB010 | C10 SB010 | i2b™ Rapid Set is a bio-engineered mixture of calcium-based inorganic compounds. i2b™ Rapid Set is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, i2b™ Rapid Set resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.i2b™ Rapid Set is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs. | i2b Rapid Set, 10g | BERKELEY ADVANCED BIOMATERIALS, LLC |
50 | 00816125023547 | C10 SB005 | C10 SB005 | i2b™ Rapid Set is a bio-engineered mixture of calcium-based inorganic compounds. i2b™ Rapid Set is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, i2b™ Rapid Set resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.i2b™ Rapid Set is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs. | i2b Rapid Set, 5g | BERKELEY ADVANCED BIOMATERIALS, LLC |