Dynex Micro

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

Vilex, LLC

The following data is part of a premarket notification filed by Vilex, Llc with the FDA for Dynex Micro.

Pre-market Notification Details

Device IDK202143
510k NumberK202143
Device Name:Dynex Micro
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant Vilex, LLC 111 Moffitt Street Mcminnville,  TN  37110
ContactJoyce Thacker
CorrespondentJoyce Thacker
Vilex, LLC 111 Moffitt Street Mcminnville,  TN  37110
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-31
Decision Date2020-09-11

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.