510(k) K192206 ยท PHX Shoulder Prosthesis, Reverse Configuration
32mm Glenosphere and Humeral Cup
| Applicant | Fx Shoulder USA, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Oct 8, 2019 |
| Received | Aug 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192206
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2025 | Merge Healthcare, Inc. Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integra Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.