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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 K140814
Device Name EVOS MINI-FRAGMENT PLATING SYSTEM
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
memphis,  TN  38116
Applicant Contact samantha staubach
Correspondent
SMITH & NEPHEW, INC.
1450 BROOKS RD.
memphis,  TN  38116
Correspondent Contact samantha staubach
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received04/01/2014
Decision Date 05/07/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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