510(k) K192365 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Shoulder Innovations Total Shoulder System
| Applicant | Shoulder Innovations, Inc., Holland MI, US |
| Decision | Substantially Equivalent, Nov 29, 2019 |
| Received | Aug 30, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192365
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.