510(k) K153248 ยท GWO Plate, Cranioplasty, Preformed, Alterable
PEEK Customized Cranial Implant
| Applicant | Stryker, Portage MI, US |
| Decision | Substantially Equivalent, Mar 10, 2016 |
| Received | Nov 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153248
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.