| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 03760154008907 | FIXIT Knotless threaded anchor | EPAV245KNO | Knotless threaded anchor for single interference in rotator cuff repair - Ø 4.5 Knotless threaded anchor for single interference in rotator cuff repair - Ø 4.5 mm, Length 11.25 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | FIXIT |
| 2 | 03760154008921 | FIXIT Knotless threaded anchor | EPAV265KNO | Knotless threaded anchor for single interference in rotator cuff repair - Ø 6.5 Knotless threaded anchor for single interference in rotator cuff repair - Ø 6.5 mm, Length 14 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | FIXIT |
| 3 | 03760154008914 | FIXIT Knotless threaded anchor | EPAV255KNO | Knotless threaded anchor for single interference in rotator cuff repair - Ø 5.5 Knotless threaded anchor for single interference in rotator cuff repair - Ø 5.5 mm, Length 14 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | FIXIT |
| 4 | 03760154008884 | FIXIT Threaded anchor system | EPA0065CLA | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 6.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | FIXIT |
| 5 | 03760154008860 | FIXIT Threaded anchor system | EPA0055CLA | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 5.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | FIXIT |
| 6 | 03760154008846 | FIXIT Threaded anchor system | EPA0047CLA | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 4.7 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | FIXIT |
| 7 | 03760304680502 | NON STERILE SAMPLE - NOT FOR IMPLANTATION | 292004 | The RIGIDLOOP adjustable juxtacortical fixation device consists of an adjustable The RIGIDLOOP adjustable juxtacortical fixation device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction threads, designed to be used for ACL reconstruction. THE SAMPLE IS NON-STERILE, NOT INTENDED FOR IMPLANTATION. | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | RIGIDLOOP Multilig Adjustable Cortical Button |
| 8 | 03760154008976 | Adjustable juxtacortical fixation device for cortical tunnel = Ø 5 to 10 mm | PULXL21202 | The Pullup® adjustable juxtacortical fixation device consists of an adjustable n The Pullup® adjustable juxtacortical fixation device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction threads, designed to be used for ACL reconstruction. The implant is supplied sterile, ready to use. | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | PULLUP |
| 9 | 03760154008969 | Adjustable juxtacortical fixation device for cortical tunnel = Ø 4.5 mm | PULLU21201 | The Pullup® adjustable juxtacortical fixation device consists of an adjustable n The Pullup® adjustable juxtacortical fixation device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction threads, designed to be used for ACL reconstruction. The implant is supplied sterile, ready to use. | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | PULLUP |
| 10 | 03760154008280 | Suture Anchor Punch Tap | 110026112 | Ø 5.5 mm & Ø 6.5 mm suture anchor punch tap | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 11 | 03760154008273 | Suture Anchor Punch Tap | 110026111 | Ø4.5 mm suture anchor punch tap | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 12 | 03760154008266 | Double loaded BroadBand suture anchor | 110026110 | Threaded anchor system Ø 6.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 13 | 03760154008259 | Double loaded BroadBand suture anchor | 110026109 | Threaded anchor system Ø 5.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 14 | 03760154008242 | Double loaded BroadBand suture anchor | 110026108 | Threaded anchor system Ø 4.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 15 | 03760154008235 | Double loaded MaxBraid suture anchor | 110026107 | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 6.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 16 | 03760154008228 | Double loaded MaxBraid suture anchor | 110026106 | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 5.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 17 | 03760154008211 | Double loaded MaxBraid suture anchor | 110026105 | Threaded anchor system for rotator cuff repair - CLASSIC - Ø 4.5 mm | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 18 | 03760154007245 | Non-sliding BroadBand | 110026115 | Threaded anchor system Ø 6.5 mm with one Blue non-sliding suture and one White/G Threaded anchor system Ø 6.5 mm with one Blue non-sliding suture and one White/Green sliding suture | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 19 | 03760154007238 | Non-sliding BroadBand | 110026114 | Threaded anchor system Ø 5.5 mm with one Blue non-sliding suture and one White/G Threaded anchor system Ø 5.5 mm with one Blue non-sliding suture and one White/Green sliding suture | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 20 | 03760154007221 | Non-sliding BroadBand | 110026113 | Threaded anchor system Ø 4.5 mm with one Blue non-sliding suture and one White/G Threaded anchor system Ø 4.5 mm with one Blue non-sliding suture and one White/Green sliding suture | MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | ComposiTCP™ |
| 21 | 03760154007924 | Screw for OTIS-C PLUS plate fixation | EVO9066080 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 22 | 03760154005142 | OTIS-C PLUS Plate - Right | EVO9067522 | 316L stainless steel mini-invasive, anatomically shaped plate for HTO. To be use 316L stainless steel mini-invasive, anatomically shaped plate for HTO. To be used with OTIS-C Plus screws. | HRS | Plate, Fixation, Bone | 2 | OTIS-C PLUS |
| 23 | 03760154005135 | OTIS-C PLUS Plate - Left | EVO9067722 | 316L stainless steel mini-invasive, anatomically shaped plate for HTO. To be use 316L stainless steel mini-invasive, anatomically shaped plate for HTO. To be used with OTIS-C Plus screws. | HRS | Plate, Fixation, Bone | 2 | OTIS-C PLUS |
| 24 | 03760154004794 | NON STERILE OTIS-C PLUS Plate | EVONS67622 | NON STERILE 316L stainless mini-invasive OTIS-C PLUS plate. | HRS | Plate, Fixation, Bone | 2 | OTIS-C PLUS |
| 25 | 03760154004770 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66027 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 26 | 03760154004756 | NON STERILE OTIS-C PLUS Left Plate | EVONS67722 | NON STERILE 316L stainless mini-invasive OTIS-C PLUS plate. | HRS | Plate, Fixation, Bone | 2 | OTIS-C PLUS |
| 27 | 03760154004749 | NON STERILE OTIS-C PLUS Right Plate | EVONS67522 | NON STERILE 316L stainless mini-invasive OTIS-C PLUS plate. | HRS | Plate, Fixation, Bone | 2 | OTIS-C PLUS |
| 28 | 03760154004732 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66030 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 29 | 03760154004718 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66050 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 30 | 03760154004701 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66036 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 31 | 03760154004695 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66033 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 32 | 03760154004497 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66055 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 33 | 03760154004480 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66065 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 34 | 03760154004459 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66039 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 35 | 03760154004190 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66060 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 36 | 03760154004169 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66042 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 37 | 03760154004152 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66070 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS p NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 38 | 03760154004145 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66045 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 39 | 03760154001397 | Screw for OTIS-C PLUS plate fixation | EVO9066075 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 40 | 03760154001281 | Screw for OTIS-C PLUS plate fixation | EVO9066070 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 41 | 03760154001274 | Screw for OTIS-C PLUS plate fixation | EVO9066065 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 42 | 03760154001267 | Screw for OTIS-C PLUS plate fixation | EVO9066060 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 43 | 03760154001250 | Screw for OTIS-C PLUS plate fixation | EVO9066055 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 44 | 03760154001243 | Screw for OTIS-C PLUS plate fixation | EVO9066050 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 45 | 03760154001236 | Screw for OTIS-C PLUS plate fixation | EVO9066045 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 46 | 03760154001229 | Screw for OTIS-C PLUS plate fixation | EVO9066042 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 47 | 03760154001212 | Screw for OTIS-C PLUS plate fixation | EVO9066039 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 48 | 03760154001205 | Screw for OTIS-C PLUS plate fixation | EVO9066036 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 49 | 03760154001199 | Screw for OTIS-C PLUS plate fixation | EVO9066033 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| 50 | 03760154001182 | Screw for OTIS-C PLUS plate fixation | EVO9066030 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | HWC | Screw, Fixation, Bone | 2 | OTIS-C PLUS |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00817771028764 | Solum IV - 20cc | 1201-0200 | Solum IV Bone Void Filler | CELLING BIOSCIENCES | |
| 2 | 00817771028757 | Solum IV - 10cc | 1201-0100 | Solum IV Bone Void Filler | CELLING BIOSCIENCES | |
| 3 | 00817771028740 | Solum IV - 5cc | 1201-0050 | Solum IV Bone Void Filler | CELLING BIOSCIENCES | |
| 4 | 00817771028733 | Solum IV - 2cc | 1201-0020 | Solum IV Bone Void Filler | CELLING BIOSCIENCES | |
| 5 | 00817771028726 | Solum IV - 1cc | 1201-0010 | Solum IV Bone Void Filler | CELLING BIOSCIENCES | |
| 6 | 00817371020632 | Solum Flow - 5cc | 1206-0050 | Solum Flow | CELLING BIOSCIENCES | |
| 7 | 00817371020625 | Solum Flow - 2cc | 1206-0020 | Solum Flow | CELLING BIOSCIENCES | |
| 8 | 00817337000074 | 6000041 | Tactoset is a synthetic, injectable, settable osteoconductive calcium phosphate Tactoset is a synthetic, injectable, settable osteoconductive calcium phosphate bone graft substitute material. | Tactoset | ANIKA THERAPEUTICS, INC. | |
| 9 | 00817337000050 | 6000041 | SCS 17-01 is a synthetic, injectable, settable osteoconductive calcium phosphate SCS 17-01 is a synthetic, injectable, settable osteoconductive calcium phosphate bone graft substitute material. | SCS 17-01 | ANIKA THERAPEUTICS, INC. | |
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | 00816986020150 | 15g | MSBG1500 | Bioactive Bone Graft Putty | UNITE Bioactive Bone Graft | BIOVENTUS LLC |
| 15 | 00816986020143 | 7.5g | MSBG0750 | Bioactive Bone Graft Putty | UNITE Bioactive Bone Graft | BIOVENTUS LLC |
| 16 | 00816986020136 | 3.75g | MSBG0375 | Bioactive Bone Graft Putty | UNITE Bioactive Bone Graft | BIOVENTUS LLC |
| 17 | 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 |
| 18 | 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 |
| 19 | 00816986020105 | 15g | OF003 | Bioactive Bone Graft Putty | OSTEOFUSE | BIOVENTUS LLC |
| 20 | 00816986020099 | 7.5g | OF002 | Bioactive Bone Graft Putty | OSTEOFUSE | BIOVENTUS LLC |
| 21 | 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 |
| 22 | 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 |
| 23 | 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 |
| 24 | 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 |
| 25 | 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 |
| 26 | 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 |
| 27 | 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 |
| 28 | 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 |
| 29 | 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 |
| 30 | 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 |
| 31 | 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 |
| 32 | 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 |
| 33 | 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 |
| 34 | 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 |
| 35 | 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 |
| 36 | 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 |
| 37 | 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 |
| 38 | 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 |
| 39 | 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 |
| 40 | 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 |
| 41 | 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 |
| 42 | 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 |
| 43 | 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 |
| 44 | 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 |
| 45 | 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 |
| 46 | 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 |
| 47 | 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 |
| 48 | 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 |
| 49 | 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 |
| 50 | 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 |