EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Encore Medical, L.P.

The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Empowr Dual Mobility Metal Liner, Empowr Dual Mobility Poly Bearing.

Pre-market Notification Details

Device IDK203557
510k NumberK203557
Device Name:EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Encore Medical, L.P. 9800 Metric Blvd. Austin,  TX  78758
ContactTeffany Hutto
CorrespondentTeffany Hutto
Encore Medical, L.P. 9800 Metric Blvd. Austin,  TX  78758
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-07
Decision Date2021-02-10

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