510(k) K203557 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Feb 10, 2021 |
| Received | Dec 7, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203557
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2025 | Encore Medical, LP Brand Name: EMPOWR Dual Mobility"
Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40
Model/Catalog Number: 952-28-40E
Software Version: NA
Product Description: The EMPOWR Dual Mo Open, Classified |
LPH | None listed |
| Jul 21, 2025 | Encore Medical, LP Brand Name: EMPOWR Dual Mobility"
Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42
Model/Catalog Number: 952-28-42F
Software Version: NA
Product Description: The EMPOWR Dual Mo Open, Classified |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.