510(k) K151382 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
Patient Contoured Implant-PEEK (PCI-PEEK)
| Applicant | KLS Martin L.P., Jacksonville FL, US |
| Decision | Substantially Equivalent, Nov 9, 2015 |
| Received | May 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151382
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.