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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K033669
Device Name SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
Applicant
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Applicant Contact DAVID HENLEY
Correspondent
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Correspondent Contact DAVID HENLEY
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/21/2003
Decision Date 12/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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