510(k) K213615 ยท PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Shoulder Innovations Total Shoulder System
| Applicant | Shoulder Innovations, Inc., Holland MI, US |
| Decision | Substantially Equivalent, Mar 11, 2022 |
| Received | Nov 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213615
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.