510(k) K250334 ยท GWO Plate, Cranioplasty, Preformed, Alterable
Fusion Craniofacial Implant; Fusion Skull Implant
| Applicant | Kelyniam Global, Inc., Canton CT, US |
| Decision | Substantially Equivalent, Jul 25, 2025 |
| Received | Feb 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250334
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.