FDA 510(k)

EMPOWR Stem Extender, 50mm

K-Number: K230441 · 2023-03-17

Decision Date2023-03-17

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EMPOWR Stem Extender, 50mm is a medical device manufactured by Encore Medical, L.P Dba Enovis. It received FDA 510(k) clearance on 2023-03-17 under approval number K230441. 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 Stem Extender, 50mm?

EMPOWR Stem Extender, 50mm is a medical device that received FDA 510(k) clearance on 2023-03-17. It is manufactured by Encore Medical, L.P Dba Enovis. The 510(k) number is K230441.

When was EMPOWR Stem Extender, 50mm approved by the FDA?

EMPOWR Stem Extender, 50mm received FDA 510(k) clearance on 2023-03-17, under approval number K230441.

What company makes EMPOWR Stem Extender, 50mm?

EMPOWR Stem Extender, 50mm is manufactured by Encore Medical, L.P Dba Enovis.

What is the FDA product code for EMPOWR Stem Extender, 50mm?

The FDA product code for EMPOWR Stem Extender, 50mm is JWH.

Other Devices by Encore Medical, L.P Dba Enovis

K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.