Data / Medical devices / United States / Berkeley Advanced Biomaterials
Berkeley Advanced Biomaterials: FDA-registered device maker in Berkeley, CA, United States, 10 510(k) clearances
Berkeley Advanced Biomaterials is registered with the FDA (registration 3014211822) in Berkeley, CA, United States. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated August 27, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014211822
- FEI number
- 3014298539
- Address
- 2800 Seventh Street, Berkeley, CA, United States, 94710
- Owner or operator
- Berkeley Advanced Biomaterials, LLC (9049267)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2027
- Brand names listed
- Accelagen Plus Surgical Matrix and Strip, B-GENIN, R-GENIN, Bi-O Plus, Bi-Ostetic, Bi-Ostetic Bioactive Glass Foam, Bi-Ostetic Foam and Putty, Bi-Ostetic Foam, Cem-Ostetic Foam, Cem-Ostetic Bone;CemO-10G,CemO-20G and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | 2 | Manufacturer | accessdata.fda.gov |
| Methyl Methacrylate For Cranioplasty | GXP | 2 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2026 | K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP) | KGN | Substantially Equivalent | Berkeley Advanced Biomaterials | accessdata.fda.gov |
| October 30, 2017 | K170917 | Bi-Ostetic Bioactive Glass Foam | MQV | Substantially Equivalent | Berkeley Advanced Biomaterials | accessdata.fda.gov |
| March 15, 2012 | K113791 | B-GENIN, R-GENIN | MQV | Substantially Equivalent | Berkeley Advanced Biomaterials, Inc. | accessdata.fda.gov |
| March 24, 2010 | K092046 | BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY | MQV | Substantially Equivalent | Berkeley Advanced Biomaterials, Inc. | accessdata.fda.gov |
| July 6, 2006 | K053213 | BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM | MQV | Substantially Equivalent | Berkeley Advanced Biomaterials, Inc. | accessdata.fda.gov |
| December 14, 2004 | K042636 | BIOPLUS | MQV | Substantially Equivalent | Berkeley Advanced Biomaterials, Inc. | accessdata.fda.gov |
| March 5, 2004 | K040405 | CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY | MQV | Substantially Equivalent | Berkeley Advanced Biomaterials, Inc. | accessdata.fda.gov |
| February 20, 2003 | K030266 | CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ | MQV | Substantially Equivalent | Berkeley Advanced Biomaterials, Inc. | accessdata.fda.gov |
| January 30, 2003 | K023703 | BI-OSTETIC | MQV | Substantially Equivalent | Berkeley Advanced Biomaterials, Inc. | accessdata.fda.gov |
| January 9, 2003 | K022622 | CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P | MQV | Substantially Equivalent | Berkeley Advanced Biomaterials, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 2, 2025 | 97601 | Class II | Ongoing | Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolate | Due to incorrect product label (Incorrect product name identified on outer packaging). | accessdata.fda.gov |
Compare with other makers
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Methyl Methacrylate For Cranioplasty
Updated August 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.