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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 K201259
Device Name ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
Applicant
Wright Medical Technology, Inc.
1023 Cherry Road
Memphis,  TN  38117
Applicant Contact Anna Hinton
Correspondent
Wright Medical Technology, Inc.
1023 Cherry Road
Memphis,  TN  38117
Correspondent Contact Anna Hinton
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/11/2020
Decision Date 01/08/2021
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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