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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K240035
Device Name TACTIX Vector Syndesmosis System
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
HTN  
Date Received01/04/2024
Decision Date 08/01/2024
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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