510(k) K230513 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Arthrex Univers Apex OptiFit Humeral Stem
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Sep 26, 2023 |
| Received | Feb 24, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230513
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.