510(k) K170917 ยท MQV Filler, Bone Void, Calcium Compound
Bi-Ostetic Bioactive Glass Foam
| Applicant | Berkeley Advanced Biomaterials, Berkeley CA, US |
| Decision | Substantially Equivalent, Oct 30, 2017 |
| Received | Mar 29, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170917
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2025 | Berkeley Advanced Biomaterials, LLC 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, p Open, Classified |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.