510(k) K121153 ยท GWO Plate, Cranioplasty, Preformed, Alterable
PEEK CUSTOMIZED CRAIAL IMPLANT KIT
| Applicant | Stryker, Portage MI, US |
| Decision | Substantially Equivalent, Sep 14, 2012 |
| Received | Apr 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121153
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.