510(k) K121102 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
| Applicant | Osteosymbionics, LLC, Stillwater MN, US |
| Decision | Substantially Equivalent, Aug 8, 2012 |
| Received | Apr 11, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121102
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.