510(k) K060445 ยท GXP Methyl Methacrylate For Cranioplasty
NORIAN CRS BONE CEMENT
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Apr 13, 2006 |
| Received | Feb 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060445
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2009 | Synthes USA (HQ), Inc. Norian CRS Rotary Mixer Cement 10cc sterile Terminated |
GXP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.