510(k) K151692 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
BioArchitects Patient Specific Cranial/Craniofacial Plate
| Applicant | Bioarchitects USA, LLC, New York NY, US |
| Decision | Substantially Equivalent, Nov 20, 2015 |
| Received | Jun 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151692
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.