510(k) K193394 ยท PHX Shoulder Prosthesis, Reverse Configuration
Humeral Cup Stability & Humeral Cup 135/145o Stability
| Applicant | Fx Shoulder USA, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Apr 29, 2020 |
| Received | Dec 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193394
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.