FDA 510(k)

EMPOWR Revision Knee

K-Number: K213793 · 2022-04-01

Decision Date2022-04-01

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EMPOWR Revision Knee is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2022-04-01 under approval number K213793. 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 Revision Knee?

EMPOWR Revision Knee is a medical device that received FDA 510(k) clearance on 2022-04-01. It is manufactured by Encore Medical L.P.. The 510(k) number is K213793.

When was EMPOWR Revision Knee approved by the FDA?

EMPOWR Revision Knee received FDA 510(k) clearance on 2022-04-01, under approval number K213793.

What company makes EMPOWR Revision Knee?

EMPOWR Revision Knee is manufactured by Encore Medical L.P..

What is the FDA product code for EMPOWR Revision Knee?

The FDA product code for EMPOWR Revision Knee 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) K160342EMPOWR PS Knee System K173073AltiVate Anatomic to Reverse Conversion Module K172651FMP Extended Liners

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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.