510(k) K182799 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Mar 8, 2019 |
| Received | Oct 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182799
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.