Treace Medical Concepts (TMC) Snap-Off Screw System

Screw, 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) Snap-off Screw System.

Pre-market Notification Details

Device IDK183363
510k NumberK183363
Device Name:Treace Medical Concepts (TMC) Snap-Off Screw System
ClassificationScrew, Fixation, Bone
Applicant Treace Medical Concepts, Inc. 203 Fort Wade Rd., Suite 150 Ponte Vedra,  FL  32081
ContactRachel Osbeck
CorrespondentDawn Norman
MRC-X, LLC 6075 Poplar Avenue, Suite 500 Memphis,  TN  38119
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-04
Decision Date2019-06-13

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