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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K230204
Device Name ALPHALOK Plating System
Applicant
Vilex LLC
111 Moffitt Street
McMinnville,  TN  37110
Applicant Contact Brock Johnson
Correspondent
Vilex LLC
111 Moffitt Street
McMinnville,  TN  37110
Correspondent Contact Brock Johnson
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received01/25/2023
Decision Date 04/25/2023
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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