510(k) K192097 · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Exactech® Equinoxe® Stemless Humeral Components
| Applicant | Exactech, Inc., Gainsville FL, US |
| Decision | Substantially Equivalent, Apr 29, 2020 |
| Received | Aug 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192097
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.