EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing— 510(k) K203557
Substantially EquivalentEncore Medical L.P.
FDA 510(k) clearance K203557 for EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing, Substantially Equivalent on 2021-02-10. Applicant: Encore Medical L.P..
Clearance details
- Applicant
- Encore Medical L.P.
- Product code
- Code LPH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Adverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.