510(k) K210861 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
| Applicant | Stryker GmbH, Mahwah NJ, US |
| Decision | Substantially Equivalent, Sep 3, 2021 |
| Received | Mar 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210861
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.