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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, Porous Uncemented
510(k) Number K150790
Device Name REDAPT Porous Acetabular Shell and Cemented Liner
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Memphis,  TN  38016
Applicant Contact JEFF SPRAGUE
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Memphis,  TN  38016
Correspondent Contact JEFF SPRAGUE
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWZ   LZO  
Date Received03/25/2015
Decision Date 11/16/2015
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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