510(k) K214001 · PHX Shoulder Prosthesis, Reverse Configuration
Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 15, 2023 |
| Received | Dec 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214001
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.