510(k) K121755 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
CUSTOM CRANIOFACIAL IMPLANT (CCI)
| Applicant | Kelyniam Global, Inc., Canton CT, US |
| Decision | Substantially Equivalent, Sep 25, 2012 |
| Received | Jun 15, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121755
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.