TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM

Plate, Fixation, Bone

TRUEMED GROUP LLC

The following data is part of a premarket notification filed by Truemed Group Llc with the FDA for Truemed Hand, Foot And Ankle Plates System.

Pre-market Notification Details

Device IDK200575
510k NumberK200575
Device Name:TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
ClassificationPlate, Fixation, Bone
Applicant TRUEMED GROUP LLC 2002 Timberloch Place Suite 200 The Woodlands,  TX  77380
ContactNina Galeana Rodriguez
CorrespondentNina Galeana Rodriguez
TRUEMED GROUP LLC 2002 Timberloch Place Suite 200 The Woodlands,  TX  77380
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-05
Decision Date2021-07-09

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