510(k) K121818 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
| Applicant | Oxford Performance Materials, South Windsor CT, US |
| Decision | Substantially Equivalent, Feb 7, 2013 |
| Received | Jun 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121818
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.