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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
510(k) Number K161610
Device Name EXPRT Revision Hip System
Applicant
Encore Medical, L.P.
9800 Metirc Blvd.
Austin,  TX  78758
Applicant Contact TEFFANY HUTTO
Correspondent
Encore Medical, L.P.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact TEFFANY HUTTO
Regulation Number888.3310
Classification Product Code
KWZ  
Subsequent Product Codes
LWJ   LZO  
Date Received06/10/2016
Decision Date 11/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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