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 IDK200961
510k NumberK200961
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
CorrespondentDanielle Besal
MRC Global 9085 East Mineral Circle, Suite Centennial,  CO  80112
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-10
Decision Date2020-05-08

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