510(k) K162697 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal
| Applicant | Custom Orthopaedic Solutions, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 10, 2017 |
| Received | Sep 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162697
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.