510(k) K253116 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
3D MAC Titanium Cranial Plate (TCP) System
| Applicant | The Surgeon General, Department of the Army (TSG-DA), Fort Detrick MD, US |
| Decision | Substantially Equivalent, Jun 18, 2026 |
| Received | Sep 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253116
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.