510(k) K212435 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Comprehensive Humeral Fracture Positioning Sleeves
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 10, 2021 |
| Received | Aug 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212435
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.