510(k) K253916 ยท HRS Plate, Fixation, Bone
APTUS Shoulder Proximal Humerus System, PentaLock 3.5
| Applicant | Medartis AG, Basel, CH |
| Decision | Substantially Equivalent, Mar 16, 2026 |
| Received | Dec 8, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253916
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.