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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 K260900
Device Name DYNEX® External Fixation Systems
Applicant
Vilex, LLC
111 Moffitt St.
Mcminnville,  TN  37110
Applicant Contact Brock Johnson
Correspondent
Vilex, LLC
111 Moffitt St.
Mcminnville,  TN  37110
Correspondent Contact Brock Johnson
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Codes
JDW   PIN  
Date Received03/18/2026
Decision Date 04/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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