510(k) K111596 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
TOTAL SHOULDER SYSTEM
| Applicant | Shoulder Innovations, LLC, Ada MI, US |
| Decision | Substantially Equivalent, Jul 5, 2011 |
| Received | Jun 8, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111596
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.