510(k) K252516 ยท PHX Shoulder Prosthesis, Reverse Configuration
N22 EZ Glenosphere
| Applicant | Shoulder Innovations, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, Jan 15, 2026 |
| Received | Aug 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252516
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.