510(k) K040864 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
| Applicant | Aesculap, Center Valley PA, US |
| Decision | Substantially Equivalent, Jun 17, 2004 |
| Received | Apr 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040864
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.