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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 K123598
Device Name SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
Applicant
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Applicant Contact Bradley Heil
Correspondent
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Correspondent Contact Bradley Heil
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
JDG   JDJ   JDQ   KWL   KWY  
KWZ   LPH   LWJ   LZO   LZY   MBL  
MEH  
Date Received11/21/2012
Decision Date 06/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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