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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
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- —
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3014298539
- DUNS Number
- —
Catalogue (346)
Page 7 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bi-Ostetic Granules | BiO-06GN | FDA UDI | Class II | Active |
| B-GENIN Putty | BG-01P | FDA UDI | Class II | Active |
| R-GENIN Putty | RG-05P | FDA UDI | Class II | Active |
| CemSyntek Putty Convenience Kit 10cc | ZS9213K-10 | FDA UDI | Class II | Active |
| PURbridge™ Active BioGlass Strip | PURbirdge-50x20x5 | FDA UDI | Class II | Active |
| EvoGraft | EBF2-50X25-10 | FDA UDI | Class II | Active |
| K2M VENADO HA/TCP Cancellous Granules | 4815-T6030 | FDA UDI | Class II | Active |
| BiSyntek Granules | ZS7-G13-5 | FDA UDI | Class II | Active |
| Cem-Ostetic Granules | CemO-01G | FDA UDI | Class II | Active |
| K2M VENADO HA/TCP Cancellous Granules | 4815-T6015 | FDA UDI | Class II | Active |
| AlexiGlass Bioactive Glass Strip | AB-3508 | FDA UDI | Class II | Active |
| R-GENIN Strip | RG2-100X25-10 | FDA UDI | Class II | Active |
| BiSyntek Granules | ZS7-G16-60 | FDA UDI | Class II | Active |
| Tribio™ Implant, 5.5mm x 40mm | M80 SB006 | FDA UDI | Class II | Active |
| B-GENIN Strip | BG1-100X25-10 | FDA UDI | Class II | Active |
| Cem-Ostetic Blocks | CemO-XYZ151505P | FDA UDI | Class II | Active |
| HA-TCP Sponge | AMWS-TCP-10 | FDA UDI | Class II | Active |
| PURcrystals™ BioCeramic NanoCrystals | PURcrystals-20 | FDA UDI | Class II | Active |
| BiSyntek BA Glass Strip | ZS8-S510-25 | FDA UDI | Class II | Active |
| Bi-Ostetic Granules | BiO-10G | FDA UDI | Class II | Active |
| Bi-Ostetic Granules | BiO-01GN | FDA UDI | Class II | Active |
| BiSyntek Granules | ZS7-G051-1 | FDA UDI | Class II | Active |
| Cem-Ostetic Granules | CemO-30G | FDA UDI | Class II | Active |
| AlexiFuse Synthetic Foam Strip | AB-3406 | FDA UDI | Class II | Active |
| AlexiGlass Bioactive Glass Putty | AB-3501 | FDA UDI | Class II | Active |
| B-GENIN Strip | BG2-50X10-02 | FDA UDI | Class II | Active |
| AlexiFuse Synthetic Foam Putty | AB-3452 | FDA UDI | Class II | Active |
| AlexiFuse Synthetic Foam Putty | AB-3451 | FDA UDI | Class II | Active |
| BiSyntek BA Glass Strip | ZS8-S510-1 | FDA UDI | Class II | Active |
| PURcrystals™ BioCeramic NanoCrystals | PURcrystals-05 | FDA UDI | Class II | Active |
| FBM-Osteo Foam Granules-Collagen Strip | FBO1-50X10-02 | FDA UDI | Class II | Active |
| Bi-Ostetic Cylinders | BiO-DZ1030P | FDA UDI | Class II | Active |
| Tri-Ostetic | K041889 | FDA 510(k) | Class II | Active |
| Cem-Ostetic Putty Injection Kit, Model Pik-Xx, Pik-Xx-Yy | K040405 | FDA 510(k) | Class II | Active |
| Bioplus | K042636 | FDA 510(k) | Class II | Active |
| B-Genin And R-Genin | K091912 | FDA 510(k) | Class II | Active |
| Bi-Ostetic Foam And Putty, Generos Foam And Putty | K092046 | FDA 510(k) | Class II | Active |
| Bi-Ostetic | K023703 | FDA 510(k) | Class II | Active |
| Generos 80, Generos 60 | K051914 | FDA 510(k) | Class II | Active |
| Marrow Plus (m+) | K051695 | FDA 510(k) | Class II | Active |
| Cem-Ostetic, Models Cemo-020o, Cemo-05p, Cemo-10p, Cemo-20p, And Cemo-30p | K022622 | FDA 510(k) | Class II | Active |
| Generos, Models Go-01g, Go-05g, Go-10g, Go-15g, Go-20g, Go-30g, Go-40g, Go-60g, Go-Xyz Series, Go-Dz Series | K050666 | FDA 510(k) | Class II | Active |
| B-Genin, R-Genin | K113791 | FDA 510(k) | Class II | Active |
| Cem-Ostetic Bone; Cemo-10g, Cemo-20g, Cemo-30g, Cemo-40g, Cemo-60g, Cem0-Xxgc; Cemo-Xyz202005p, Cemo-Xyz20210p, Cemo-Xyz | K030266 | FDA 510(k) | Class II | Active |
| Bi-Ostetic Bioactive Glass Foam | K170917 | FDA 510(k) | Class II | Active |
| Bi-Ostetic Foam, Cem-Ostetic Foam, Tri-Ostetic Foam, Generos Foam | K053213 | FDA 510(k) | Class II | Active |
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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). |