510(k) K153115 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Arthrex Univers Apex, Size 5 Stem
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Nov 23, 2015 |
| Received | Oct 28, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153115
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.