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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 K163039
Device Name ORTHOLOC® 3Di Small Bones Plating
Applicant
Wright Medical Technology, Inc.
1023 Cherry Road
Memphis,  TN  38117
Applicant Contact Michael Mullins
Correspondent
Wright Medical Technology, Inc.
1023 Cherry Road
Memphis,  TN  38117
Correspondent Contact Michael Mullins
Regulation Number888.3030
Classification Product Code
HRS  
Date Received10/31/2016
Decision Date 03/13/2017
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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