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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 K192504
Device Name Treace Medical Concepts (TMC) Plating System
Treace Medical Concepts, Inc.
203 Fort Wade Rd., Suite 150
ponte vedra,  FL  32081
Applicant Contact rachel osbeck
Memphis Regulatory Consulting, LLC
6075 Poplar Avenue, Suite 500
memphis,  TN  38119
Correspondent Contact dawn norman
Regulation Number888.3030
Classification Product Code
Subsequent Product Code
Date Received09/12/2019
Decision Date 10/30/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No