Treace Medical Concepts (TMC) Plating System

Plate, Fixation, Bone

Treace Medical Concepts, Inc.

The following data is part of a premarket notification filed by Treace Medical Concepts, Inc. with the FDA for Treace Medical Concepts (tmc) Plating System.

Pre-market Notification Details

Device IDK183321
510k NumberK183321
Device Name:Treace Medical Concepts (TMC) Plating System
ClassificationPlate, Fixation, Bone
Applicant Treace Medical Concepts, Inc. 203 Fort Wade Rd., Suite 150 Ponte Vedra,  FL  32081
ContactRachel Osbeck
CorrespondentDawn Norman
Memphis Regulatory Consulting, LLC 6075 Poplar Avenue, Suite 500 Memphis,  TN  38119
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-30
Decision Date2019-01-25
Summary:summary

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