510(k) K260709 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)
| Applicant | Longeviti Neuro Solutions, Baltimore MD, US |
| Decision | Substantially Equivalent, Jun 25, 2026 |
| Received | Mar 4, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260709
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.