510(k) K042340 ยท MQV Filler, Bone Void, Calcium Compound
KASIOS TCP
| Applicant | Kasios Biomaterials, Temecula CA, US |
| Decision | Substantially Equivalent, Nov 24, 2004 |
| Received | Aug 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042340
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2016 | Acumed LLC OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt. Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.