510(k) K111065 ยท GWO Plate, Cranioplasty, Preformed, Alterable
STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
| Applicant | Howmedica Osteonics Corp. Dba Stryker Orthopeadics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Jul 14, 2011 |
| Received | Apr 18, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111065
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.