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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K202143
Device Name Dynex Micro
Applicant
Vilex, LLC
111 Moffitt St.
Mcminnville,  TN  37110
Applicant Contact Joyce Thacker
Correspondent
Vilex, LLC
111 Moffitt St.
Mcminnville,  TN  37110
Correspondent Contact Joyce Thacker
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received07/31/2020
Decision Date 09/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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