510(k) K122353 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
CRAINFIX 2 TITANIUM CLAMP SYSTEM
| Applicant | Aesculap, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Aug 30, 2012 |
| Received | Aug 3, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122353
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.