Berkeley Advanced Biomaterials
Berkeley, CA, US
Berkeley Advanced Biomaterials appears in FDA device records in Berkeley, CA. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Berkeley Advanced Biomaterials between 2003 and 2017. The busiest year on record is 2003, with 3. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 3 |
| 2004 | 3 |
| 2005 | 3 |
| 2006 | 1 |
| 2010 | 2 |
| 2012 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170917 | Bi-Ostetic Bioactive Glass Foam | MQV | Substantially Equivalent | |
| K113791 | B-GENIN, R-GENIN | MQV | Substantially Equivalent | |
| K091912 | B-GENIN AND R-GENIN | MQV | Substantially Equivalent | |
| K092046 | BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY | MQV | Substantially Equivalent | |
| K053213 | BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM | MQV | Substantially Equivalent | |
| K051914 | GENEROS 80, GENEROS 60 | MQV | Substantially Equivalent | |
| K051695 | MARROW PLUS (M+) | MQV | Substantially Equivalent | |
| K050666 | GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES | MQV | Substantially Equivalent | |
| K042636 | BIOPLUS | MQV | Substantially Equivalent | |
| K041889 | TRI-OSTETIC | MQV | Substantially Equivalent | |
| K040405 | CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY | MQV | Substantially Equivalent | |
| 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 | |
| K023703 | BI-OSTETIC | MQV | Substantially Equivalent | |
| K022622 | CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P | MQV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014211822 | 3014298539 | Berkeley Advanced Biomaterials | 2800 Seventh Street, Berkeley, CA 94710 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0540-2026 | 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 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. | Due to incorrect product label (Incorrect product name identified on outer packaging). | Class II | Open, Classified |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Berkeley Advanced Biomaterials edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain