510(k) K250297 ยท GWO Plate, Cranioplasty, Preformed, Alterable
TECHFIT Patient-Specific Cranial System
| Applicant | Techfit Digital Surgery, Inc., Daytona Beach FL, US |
| Decision | Substantially Equivalent, Oct 27, 2025 |
| Received | Jan 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250297
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.