FDA 510(k)

EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing

K-Number: K203557 · 2021-02-10

Decision Date2021-02-10

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2021-02-10 under 510(k) 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. The listed applicant is Encore Medical L.P.. The 510(k) number is K203557.

When did EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing receive FDA 510(k) clearance?

EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing received FDA 510(k) clearance on 2021-02-10, under 510(k) number K203557.

Who is the listed applicant for EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

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

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NCT04090359Dual Mobility Acetabular Cups in Revision TJARECRUITING NCT06941558The UK ADAPTIS StudyACTIVE_NOT_RECRUITING

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Related Devices (Code: LPH)

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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.