510(k) K254084 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
AETOS Shoulder System - CONCELOC Glenoids
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Apr 6, 2026 |
| Received | Dec 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254084
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.