510(k) K180064 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
OsteoFab Patient Specific Cranial Device
| Applicant | Oxford Performance Materials, Inc., South Windsor CT, US |
| Decision | Substantially Equivalent, Jul 27, 2018 |
| Received | Jan 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180064
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.