510(k) K243715 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
Synthes Patient Specific Implants
| Applicant | Synthes GmbH, Zuchwil, CH |
| Decision | Substantially Equivalent, Nov 12, 2025 |
| Received | Dec 2, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243715
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.