510(k) K142072 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
| Applicant | Custom Orthopaedic Solutions, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Nov 24, 2014 |
| Received | Jul 23, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142072
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.