FDA 510(k)

EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing

Numéro K : K203557 · 2021-02-10

Date de décision2021-02-10

Code produitLPH

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

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Source officielle

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