510(k) K051093 ยท GXP Methyl Methacrylate For Cranioplasty
OSTEOPORE PCL SCAFFOLD
| Applicant | Osteopore, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Mar 17, 2006 |
| Received | Apr 28, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051093
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | OSTEOPORE INTERNATIONAL PTE LTD Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh. Terminated |
GXP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.