510(k) K161863 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
| Applicant | Stryker GmbH, Selzach, CH |
| Decision | Substantially Equivalent, Nov 23, 2016 |
| Received | Jul 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161863
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.