510(k) K253291 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Excelsior System
| Applicant | Blue Ocean Global, Miami FL, US |
| Decision | Substantially Equivalent, Jan 20, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253291
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.