510(k) K254087 · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
| Applicant | Synthes (USA) Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Jun 11, 2026 |
| Received | Dec 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254087
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.