510(k) K031654 ยท GXR Cover, Burr Hole
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Aug 8, 2003 |
| Received | May 28, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031654
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.