510(k) K153215 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
SmartBase for Arthrex Glenoid IRIS
| Applicant | Custom Orthopaedic Solutions, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 19, 2016 |
| Received | Nov 5, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153215
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.