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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 K153531
Device Name Treace Medical Concepts (TMC) Plating System
Applicant
Treace Medical Concepts, Inc.
3107 Sawgrass Village Circle
Ponte Vedra Beach,  FL  32082
Applicant Contact JOE FERGUSON
Correspondent
Memphis Regulatory Consulting, LLC
3416 Roxee Run Cove
Bartlett,  TN  38133
Correspondent Contact KIMBERLY STROHKIRCH
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/09/2015
Decision Date 01/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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