510(k) K053199 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Dec 14, 2005 |
| Received | Nov 16, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053199
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.