| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | ECUR449100 | 100x25x4mm | 1 x 10 cc | Device Name: Matriform StripIndication for Use:Matriform® Si Strip is intended t Device Name: Matriform StripIndication for Use:Matriform® Si Strip is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Matriform® Si Strip is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process | MQV | Filler, Bone Void, Calcium Compound | 2 | Matriform SI-Strip |
| 2 | ECUR449050 | 50x25x4 mm | 1 x 5 cc | Device Name: Matriform SI-StripIndication for Use:Matriform® Si Strip is intende Device Name: Matriform SI-StripIndication for Use:Matriform® Si Strip is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Matriform® Si Strip is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process | MQV | Filler, Bone Void, Calcium Compound | 2 | Matriform SI-Strip |
| 3 | ECURH20M1000 | 1000-2000µm | 1 x 2.0 cc | Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for t Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes | LYC | Bone Grafting Material, Synthetic | 2 | Osbone Dental |
| 4 | ECURH20V0250 | 250-1000µm | 1 x 2.0 cc | Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for t Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes | LYC | Bone Grafting Material, Synthetic | 2 | Osbone Dental |
| 5 | ECURH10V1000 | 1000-2000µm | 1 x 1.0 cc | Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for t Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes | LYC | Bone Grafting Material, Synthetic | 2 | Osbone Dental |
| 6 | ECURH10V0250 | 250-1000µm | 1 x 1.0 cc | Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for t Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes | LYC | Bone Grafting Material, Synthetic | 2 | Osbone Dental |
| 7 | ECURH10M1000 | 1000-2000µm | 5 x 1.0 cc | Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for t Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes | LYC | Bone Grafting Material, Synthetic | Osbone Dental | |
| 8 | ECURH10M0250 | 250-1000µm | 5 x 1.0 cc | Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for t Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes | LYC | Bone Grafting Material, Synthetic | Osbone Dental | |
| 9 | ECURH05V1000 | 1000-2000µm | 1 x 0.5 cc | Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for t Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes | LYC | Bone Grafting Material, Synthetic | 2 | Osbone Dental |
| 10 | ECURH05V0250 | 250-1000µm | 1 x 0.5 cc | Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes | LYC | Bone Grafting Material, Synthetic | 2 | Osbone Dental |
| 11 | ECURH05M1000 | 1000-2000µm | 5 x 0.5 cc | Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for t Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes | LYC | Bone Grafting Material, Synthetic | Osbone Dental | |
| 12 | ECURH05M0250 | 250-1000µm | 5 x 0.5 cc | Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes | LYC | Bone Grafting Material, Synthetic | Osbone Dental | |
| 13 | ECUR409050 | 25x50x4 mm | 1 x 5 cc | Device Name: Matriform LargeMofidication: Mouldable FoamIndication for Use:Matri Device Name: Matriform LargeMofidication: Mouldable FoamIndication for Use:Matriform Large is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Matriform Large resorbs and is replaced with bone during healing process. | MQV | Filler, Bone Void, Calcium Compound | 2 | Matriform Large |
| 14 | ECURS20M1000 | 1000-2000µm | 5 x 2.0 cc | Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recomm Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | LYC | Bone Grafting Material, Synthetic | Cerasorb M Dental | |
| 15 | ECURS20M0500 | 500-1000µm | 5 x 2.0 cc | Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recomm Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | LYC | Bone Grafting Material, Synthetic | Cerasorb M Dental | |
| 16 | ECURS20M0150 | 150-500µm | 5 x 2.0 cc | Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recomm Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | LYC | Bone Grafting Material, Synthetic | Cerasorb M Dental | |
| 17 | ECURS10V0500 | 500-1000µm | 1 x 1.0 cc | Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recomm Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | LYC | Bone Grafting Material, Synthetic | 2 | Cerasorb M Dental |
| 18 | ECURS10M1000 | 1000-2000µm | 5 x 1.0 cc | Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recomm Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | LYC | Bone Grafting Material, Synthetic | Cerasorb M Dental | |
| 19 | ECURS10M0500 | 500-1000µm | 5 x 1.0 cc | Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recomm Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | LYC | Bone Grafting Material, Synthetic | Cerasorb M Dental | |
| 20 | ECURS10M0150 | 150-500µm | 5 x 1.0 cc | Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recomm Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | LYC | Bone Grafting Material, Synthetic | Cerasorb M Dental | |
| 21 | ECURS05V0500 | 500-1000µm | 1 x 0.5 cc | Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recomm Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | LYC | Bone Grafting Material, Synthetic | 2 | Cerasorb M Dental |
| 22 | ECURS05M1000 | 1000-2000µm | 5 x 0.5 cc | Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recomm Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | LYC | Bone Grafting Material, Synthetic | Cerasorb M Dental | |
| 23 | ECURS05M0500 | 500-1000µm | 5 x 0.5 cc | Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recomm Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | LYC | Bone Grafting Material, Synthetic | Cerasorb M Dental | |
| 24 | ECURS05M0150 | 150-500µm | 5 x 0.5 cc | Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recomm Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | LYC | Bone Grafting Material, Synthetic | Cerasorb M Dental | |
| 25 | ECURCOF2550 | 25x50x4 mm | 1 x 0.5 cc | Device Name: CERASORB® Ortho FoamMofidication: Flexible Foam StripeIndication fo Device Name: CERASORB® Ortho FoamMofidication: Flexible Foam StripeIndication for Use:Cerasorb® ORTHO Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process. | MQV | Filler, Bone Void, Calcium Compound | 2 | CERASORB® Ortho Foam |
| 26 | ECURCOF25100 | 25x100x4 mm | 1 x 10.0 cc | Device Name: CERASORB® Ortho FoamMofidication: Flexible Foam StripeIndication fo Device Name: CERASORB® Ortho FoamMofidication: Flexible Foam StripeIndication for Use:Cerasorb® ORTHO Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process. | MQV | Filler, Bone Void, Calcium Compound | 2 | CERASORB® Ortho Foam |
| 27 | ECURCOM2550 | 25x50x4 mm | 1 x 5.0 cc | Device Name: CERASORB® Ortho FoamMofidication: Mouldable FoamIndication for Use: Device Name: CERASORB® Ortho FoamMofidication: Mouldable FoamIndication for Use:Cerasorb® ORTHO Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process. | MQV | Filler, Bone Void, Calcium Compound | 2 | CERASORB® Ortho Foam |
| 28 | ECURCOM2512 | 25x12x4 mm | 1 x 1.2 cc | Device Name: CERASORB® Ortho FoamMofidication: Mouldable FoamIndication for Use: Device Name: CERASORB® Ortho FoamMofidication: Mouldable FoamIndication for Use:Cerasorb® ORTHO Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process. | MQV | Filler, Bone Void, Calcium Compound | 2 | CERASORB® Ortho Foam |
| 29 | ECURCOM25100 | 25x100x4 mm | 1 x 10.0cc | Device Name: CERASORB® Ortho FoamMofidication: Mouldable FoamIndication for Use: Device Name: CERASORB® Ortho FoamMofidication: Mouldable FoamIndication for Use:Cerasorb® ORTHO Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process. | MQV | Filler, Bone Void, Calcium Compound | 2 | CERASORB® Ortho Foam |
| 30 | ECURCOF6565 | 65x65x6 mm | 1 x 25.0 cc | Device Name: CERASORB® Ortho FoamMofidication: Flexible Foam StripeIndication fo Device Name: CERASORB® Ortho FoamMofidication: Flexible Foam StripeIndication for Use:Cerasorb® ORTHO Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process. | MQV | Filler, Bone Void, Calcium Compound | 2 | CERASORB® Ortho Foam |
| 31 | 42604764313268 | 1-2mm | 1x2cc | Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistr Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge | LYC | Bone Grafting Material, Synthetic | 2 | IngeniOS HA |
| 32 | 42604764313190 | 1-2mm | 1x1cc | Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistr Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge | LYC | Bone Grafting Material, Synthetic | 2 | IngeniOS HA |
| 33 | 42604764313022 | 1-2mm | 1x0.5cc | Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistr Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge | LYC | Bone Grafting Material, Synthetic | 2 | IngeniOS HA |
| 34 | 42604764312346 | 0.25-1mm | 1x2cc | Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistr Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge | LYC | Bone Grafting Material, Synthetic | 2 | IngeniOS HA |
| 35 | 42604764312278 | 0.25-1mm | 1x1cc | Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistr Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge | LYC | Bone Grafting Material, Synthetic | 2 | IngeniOS HA |
| 36 | 42604764312100 | 0.25-1mm | 1x0.5cc | Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistr Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge | LYC | Bone Grafting Material, Synthetic | 2 | IngeniOS HA |
| 37 | 42604764312032 | 0.25-1mm | 1x0.25cc | Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistr Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge | LYC | Bone Grafting Material, Synthetic | 2 | IngeniOS HA |
| 38 | 42604764311288 | 1-2mm | 1x2cc | Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use:Oral and maxillofacial surgery and dentistry• Augmentation or reconstructive treatment of the alveolar ridge• Filling of infrabony periodontal defects• Filling of defects after root resection, apicoectomy, and cystectomy• Filing of extraction sockets to enhance preservation of the alveolar ridge• Elevation of the maxillary sinus floor | LPK | Bone Grafting Material, For Dental Bone Repair | 2 | IngeniOS ß-TCP Bioactiv Synthetic Bone Particles |
| 39 | 42604764311110 | 1-2mm | 1x1cc | Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use:Oral and maxillofacial surgery and dentistry• Augmentation or reconstructive treatment of the alveolar ridge• Filling of infrabony periodontal defects• Filling of defects after root resection, apicoectomy, and cystectomy• Filing of extraction sockets to enhance preservation of the alveolar ridge• Elevation of the maxillary sinus floor | LPK | Bone Grafting Material, For Dental Bone Repair | 2 | IngeniOS ß-TCP Bioactiv Synthetic Bone Particles |
| 40 | 42604764311042 | 1-2mm | 1x0.5cc | Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use:Oral and maxillofacial surgery and dentistry• Augmentation or reconstructive treatment of the alveolar ridge• Filling of infrabony periodontal defects• Filling of defects after root resection, apicoectomy, and cystectomy• Filing of extraction sockets to enhance preservation of the alveolar ridge• Elevation of the maxillary sinus floor | LPK | Bone Grafting Material, For Dental Bone Repair | 2 | IngeniOS ß-TCP Bioactiv Synthetic Bone Particles |
| 41 | 42604764310366 | 0.25-1mm | 1x2cc | Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use:Oral and maxillofacial surgery and dentistry• Augmentation or reconstructive treatment of the alveolar ridge• Filling of infrabony periodontal defects• Filling of defects after root resection, apicoectomy, and cystectomy• Filing of extraction sockets to enhance preservation of the alveolar ridge• Elevation of the maxillary sinus floor | LPK | Bone Grafting Material, For Dental Bone Repair | 2 | IngeniOS ß-TCP Bioactiv Synthetic Bone Particles |
| 42 | 42604764310298 | 0.25-1mm | 1x1cc | Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use:Oral and maxillofacial surgery and dentistry• Augmentation or reconstructive treatment of the alveolar ridge• Filling of infrabony periodontal defects• Filling of defects after root resection, apicoectomy, and cystectomy• Filing of extraction sockets to enhance preservation of the alveolar ridge• Elevation of the maxillary sinus floor | LPK | Bone Grafting Material, For Dental Bone Repair | 2 | IngeniOS ß-TCP Bioactiv Synthetic Bone Particles |
| 43 | 42604764310120 | 0.25-1mm | 1x0.5cc | Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use:Oral and maxillofacial surgery and dentistry• Augmentation or reconstructive treatment of the alveolar ridge• Filling of infrabony periodontal defects• Filling of defects after root resection, apicoectomy, and cystectomy• Filing of extraction sockets to enhance preservation of the alveolar ridge• Elevation of the maxillary sinus floor | LPK | Bone Grafting Material, For Dental Bone Repair | 2 | IngeniOS ß-TCP Bioactiv Synthetic Bone Particles |
| 44 | 42604764310052 | 0.25-1mm | 1x0.25cc | Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use:Oral and maxillofacial surgery and dentistry• Augmentation or reconstructive treatment of the alveolar ridge• Filling of infrabony periodontal defects• Filling of defects after root resection, apicoectomy, and cystectomy• Filing of extraction sockets to enhance preservation of the alveolar ridge• Elevation of the maxillary sinus floor | LPK | Bone Grafting Material, For Dental Bone Repair | 2 | IngeniOS ß-TCP Bioactiv Synthetic Bone Particles |
| 45 | 04260476431326 | 1-2mm | 1x2cc | Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistr Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge | LYC | Bone Grafting Material, Synthetic | 2 | IngeniOS HA |
| 46 | 04260476431319 | 1-2mm | 1x1cc | Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistr Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge | LYC | Bone Grafting Material, Synthetic | 2 | IngeniOS HA |
| 47 | 04260476431302 | 1-2mm | 1x0.5cc | Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistr Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge | LYC | Bone Grafting Material, Synthetic | 2 | IngeniOS HA |
| 48 | 04260476431234 | 0.25-1mm | 1x2cc | Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistr Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge | LYC | Bone Grafting Material, Synthetic | 2 | IngeniOS HA |
| 49 | 04260476431012 | 0.25-1mm | 1x0.5cc | Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use:Oral and maxillofacial surgery and dentistry• Augmentation or reconstructive treatment of the alveolar ridge• Filling of infrabony periodontal defects• Filling of defects after root resection, apicoectomy, and cystectomy• Filing of extraction sockets to enhance preservation of the alveolar ridge• Elevation of the maxillary sinus floor | LPK | Bone Grafting Material, For Dental Bone Repair | 2 | IngeniOS ß-TCP Bioactiv Synthetic Bone Particles |
| 50 | 04260476431227 | 0.25-1mm | 1x1cc | Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistr Device Name: IngeniOS HAIndications for Use:Oral-maxillofacial surgery, dentistry, implantology, periodontology• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolar ridge preservation• Filling of extraction defects to create an implant bed• Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects• Support function for a membrane in guided tissue regeneration (GTR)• Defects after surgical removal of retained teeth or corrective osteotomies• Other multi-walled bone defects of the alveolar ridge | LYC | Bone Grafting Material, Synthetic | 2 | IngeniOS HA |
| 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 |