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FDA 510(k)

EMPOWR PS Knee System

K-Number: K160342 · 2016-05-19

ApplicantEncore Medical L.P.
Decision Date2016-05-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMPOWR PS Knee System is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2016-05-19 under approval number K160342. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPOWR PS Knee System?

EMPOWR PS Knee System is a medical device that received FDA 510(k) clearance on 2016-05-19. It is manufactured by Encore Medical L.P.. The 510(k) number is K160342.

When was EMPOWR PS Knee System approved by the FDA?

EMPOWR PS Knee System received FDA 510(k) clearance on 2016-05-19, under approval number K160342.

What company makes EMPOWR PS Knee System?

EMPOWR PS Knee System is manufactured by Encore Medical L.P..

What is the FDA product code for EMPOWR PS Knee System?

The FDA product code for EMPOWR PS Knee System is JWH.

Other Devices by Encore Medical L.P.

K162024AltiVate Anatomic Shoulder System K161610EXPRT Revision Hip System K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) K173073AltiVate Anatomic to Reverse Conversion Module K172651FMP Extended Liners K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert

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Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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.

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