510(k) K110684 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
| Applicant | Vanduzen Dba Medcad, Richardson TX, US |
| Decision | Substantially Equivalent, Jun 24, 2011 |
| Received | Mar 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110684
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.