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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K230441
Device Name EMPOWR Stem Extender, 50mm
Applicant
Encore Medical, L.P Dba Enovis
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact Thorsen Trey
Correspondent
Encore Medical, L.P Dba Enovis
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact Thorsen Trey
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/21/2023
Decision Date 03/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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