510(k) K182516 ยท PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Comprehensive Nano Stemless Shoulder
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 22, 2019 |
| Received | Sep 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182516
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.