510(k) K100741 ยท PHX Shoulder Prosthesis, Reverse Configuration
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Aug 2, 2010 |
| Received | Mar 16, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100741
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2026 | Encore Medical, LP Brand Name: Reverse Shoulder Prosthesis (RSP)
Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus
Model/Catalog Number: 509-00-432 Open, Classified |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.