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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 K170887
Device Name EVOS Small Fragment Plating System
Applicant
Smith & Nephew, Inc.
1450 Brooks Road
Memphis,  TN  38116
Applicant Contact Samantha Staubach
Correspondent
Smith & Nephew, Inc.
1450 Brooks Road
Memphis,  TN  38116
Correspondent Contact Samantha Staubach
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received03/27/2017
Decision Date 04/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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