510(k) K133834 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
DEPUY GLOBAL UNITE SHOULDER SYSTEM
| Applicant | Depuy(Ireland), Co. Cork, IE |
| Decision | Substantially Equivalent, Apr 3, 2014 |
| Received | Dec 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133834
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2018 | DePuy Orthopaedics, Inc. The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pdf.pdf, LEO-1100-40-0 Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.