510(k) K033868 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Jun 21, 2004 |
| Received | Dec 12, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033868
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.