510(k) K040047 ยท MQV Filler, Bone Void, Calcium Compound
POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
| Applicant | Osteobiologics, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Dec 17, 2004 |
| Received | Jan 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040047
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 30, 2006 | Smith & Nephew, Inc. Endoscopy Division TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX. Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.