EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
K-Number: K203557 · 2021-02-10
ApplicantEncore Medical L.P.
Decision Date2021-02-10
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2021-02-10 under approval number K203557. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing?
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing is a medical device that received FDA 510(k) clearance on 2021-02-10. It is manufactured by Encore Medical L.P.. The 510(k) number is K203557.
When was EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing approved by the FDA?
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing received FDA 510(k) clearance on 2021-02-10, under approval number K203557.
What company makes EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing?
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing is manufactured by Encore Medical L.P..
What is the FDA product code for EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing?
The FDA product code for EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing is LPH.
Related Clinical Trials
NCT07592325
Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis
RECRUITING
NCT04090359
Dual Mobility Acetabular Cups in Revision TJA
RECRUITING
NCT06934694
Effect of Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius Stiffness and Ankle Range of Motion
COMPLETED
NCT06941558
The UK ADAPTIS Study
ACTIVE_NOT_RECRUITING
NCT07092579
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures
RECRUITING
NCT07138066
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures
RECRUITING
Other Devices by Encore Medical L.P.
Related Devices (Code: LPH)
K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.
K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.
K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
K161184iNSitu Total Hip SystemTheken Companies, LLC
K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC
K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.