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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K151902
Device Name REDAPT¿ Revision Femoral System
Applicant
SMITH & NEPHEW, INC.
7135 GOODLETT FARMS PARKWAY
CORDOVA,  TN  38016
Applicant Contact Natalie P. Williams
Correspondent
SMITH & NEPHEW, INC.
7135 GOODLETT FARMS PARKWAY
CORDOVA,  TN  38016
Correspondent Contact Natalie P Williams
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received07/10/2015
Decision Date 09/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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