510(k) K151500 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)
| Applicant | Custom Orthopaedic Solutions, Cleveland OH, US |
| Decision | Substantially Equivalent, Oct 5, 2015 |
| Received | Jun 4, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151500
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.