510(k) K254054 · HRS Plate, Fixation, Bone
VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System
| Applicant | Synthes GmbH, Zuchwil, CH |
| Decision | Substantially Equivalent, Mar 2, 2026 |
| Received | Dec 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254054
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.