510(k) K261058 ยท GWO Plate, Cranioplasty, Preformed, Alterable
CraniUS Plate
| Applicant | CraniUS, LLC, Baltimore MD, US |
| Decision | Substantially Equivalent, Jul 29, 2026 |
| Received | Mar 31, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261058
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.