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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 K151881
Device Name X-Fix Line Additions
Applicant
Vilex IN Tennessee, Inc.
111 Moffitt St.
Mcminnville,  TN  37110
Applicant Contact SYLVIA SOUTHARD
Correspondent
Vilex, Inc.
8374 Market St., #167
Lakewood Ranch,  FL  34202
Correspondent Contact ABRAHAM LAVI
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
OSN  
Date Received07/09/2015
Decision Date 03/24/2016
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
Recalls CDRH Recalls
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