Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBerkeley Advanced Biomaterials
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2800 Seventh Street, Berkeley, CA, 94710
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3014298539
- DUNS Number
- —
Catalogue (346)
Page 3 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OptiFuse BA 12.5cc Strip | 7888-0125 | FDA UDI | Class II | Active |
| BiSyntek Strip | ZS7-2S5025-10 | FDA UDI | Class II | Unknown |
| BiSyntek BA Glass Strip | ZS8-S125-10 | FDA UDI | Class II | Active |
| BiSyntek Granules | ZS7-G051-2 | FDA UDI | Class II | Active |
| BiSyntek Strip | ZS7-S5010-1 | FDA UDI | Class II | Active |
| Putty Convenience Kit, 5cc | PCK-05 | FDA UDI | Class II | Active |
| Cem-Ostetic Putty | CemO-07PG | FDA UDI | Class II | Active |
| B-GENIN Strip | BG1-50X10-01 | FDA UDI | Class II | Active |
| Tribio™ Implant, 7.5mm x 40mm | M80 SB008 | FDA UDI | Class II | Active |
| SeaSpine Bi-Ostetic Cancellous Block, 40x6x6mm | SBiO-XYZ400606P | FDA UDI | Class II | Active |
| FBM-Osteo Foam Granules-Collagen Strip | FBO1-50X10-01 | FDA UDI | Class II | Active |
| EvoGraft | EBF1-90X22-10 | FDA UDI | Class II | Active |
| K2M VENADO HA/TCP Granules-Collagen Strip | 4815-T1001 | FDA UDI | Class II | Active |
| Bi-Ostetic Foam Strip | BF1-50X25-02 | FDA UDI | Class II | Active |
| HA-TCP-Bioglass Sponge | ARM-TCP-BA-12 | FDA UDI | Class II | Active |
| Cem-Ostetic Granules | CemO-10G | FDA UDI | Class II | Active |
| Bi-Ostetic Bioactive Glass Foam | AA1-100X25-12 | FDA UDI | Class II | Active |
| Bi-Ostetic Foam Strip | BF2-50X10-02 | FDA UDI | Class II | Active |
| Cem-Ostetic Putty | CemO-01M | FDA UDI | Class II | Active |
| Bi-Ostetic Bioactive Glass Foam | AA1-7D40-01 | FDA UDI | Class II | Active |
| R-GENIN Strip | RG1-100X25-05 | FDA UDI | Class II | Active |
| EvoGraft | EBF1-100X25-10 | FDA UDI | Class II | Active |
| NexGraft | NBF2-50X10-02 | FDA UDI | Class II | Unknown |
| B-GENIN Strip | BGT-50X25-05 | FDA UDI | Class II | Active |
| PURpillars™ Advanced Collagen Matrix Strip | PURpillars-50x20x5 | FDA UDI | Class II | Active |
| B-GENIN Strip | BGT-100x25-10 | FDA UDI | Class II | Active |
| BiSyntek BA Glass Putty | ZS8213-5P | FDA UDI | Class II | Active |
| AlexiGlass Bioactive Glass Putty | AB-3503 | FDA UDI | Class II | Active |
| CemSyntek Putty | ZS9213-20P | FDA UDI | Class II | Active |
| Bi-Ostetic Foam Strip | BF1-100X25-20 | FDA UDI | Class II | Active |
| Bi-Ostetic Foam Strip | BF2-15X10-01 | FDA UDI | Class II | Active |
| Bi-Ostetic Blocks | BiO-XYZ400606P | FDA UDI | Class II | Active |
| Cem-Ostetic Granules | CemO-02G | FDA UDI | Class II | Active |
| BiSyntek BA Glass Putty | ZS8213-2P | FDA UDI | Class II | Active |
| PURcrystals™ BioCeramic NanoCrystals | PURcrystals-15 | FDA UDI | Class II | Active |
| NexGraft | NBF1-90X22-07 | FDA UDI | Class II | Unknown |
| BiSyntek Strip | ZS7-2S5025-10 | FDA UDI | Class II | Unknown |
| Cem-Ostetic Cylinder | CemO-DZ1020P | FDA UDI | Class II | Active |
| BiSyntek BA Glass Strip | ZS8-S125-15 | FDA UDI | Class II | Active |
| EvoGraft | EBF1-50X10-02 | FDA UDI | Class II | Active |
| OptiFuse BA Moldable Matrix | 7888-0625 | FDA UDI | Class II | Active |
| B-GENIN Strip | BG5-100X5-12 | FDA UDI | Class II | Active |
| Bi-Ostetic Bioactive Glass Foam | AA1-50X25-06 | FDA UDI | Class II | Active |
| R-GENIN Strip | RG2-50X10-05 | FDA UDI | Class II | Active |
| NexGraft | NBF1-50X10-02 | FDA UDI | Class II | Unknown |
| BiSyntek Granules | ZS7-G16-30 | FDA UDI | Class II | Active |
| Cem-Ostetic Blocks | CemO-XYZ202005P | FDA UDI | Class II | Active |
| NexGraft | NBF1-90X22-10 | FDA UDI | Class II | Unknown |
| Bi-Ostetic Granules | BiO-05GN | FDA UDI | Class II | Active |
| BiSyntek Granules | ZS7-G13-10 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 2, 2025 | Z-0540-2026 | — | open, classified | Due to incorrect product label (Incorrect product name identified on outer packaging). |