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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 K163650
Device Name ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
Applicant
Wright Medical Technology, Inc.
1023 Cherry Road
Memphis,  TN  38117
Applicant Contact Rachel Roberts
Correspondent
Wright Medical Technology, Inc.
1023 Cherry Road
Memphis,  TN  38117
Correspondent Contact Rachel Roberts
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/23/2016
Decision Date 04/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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