510(k) K222936 · PHX Shoulder Prosthesis, Reverse Configuration
Humeris® 135 Shoulder System
| Applicant | Fx Shoulder USA, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Nov 7, 2022 |
| Received | Sep 26, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222936
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.