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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, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K160923
Device Name REDAPT Anteverted Cemented Liner
Applicant
SMITH & NEPHEW, INC.
7135 GOODLETT FARMS PARKWAY
CORDOVA,  TN  38016
Applicant Contact KIM PHAN
Correspondent
SMITH & NEPHEW, INC.
7135 GOODLETT FARMS PARKWAY
CORDOVA,  TN  38016
Correspondent Contact KIM PHAN
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KWZ   LZO  
Date Received04/04/2016
Decision Date 11/17/2016
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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