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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 K052196
Device Name VILEX X-FIX
Applicant
VILEX, INC.
345 OLD CURRY HOLLOW RD.
PLEASANT HILLS,  PA  15236
Applicant Contact ABRAHAM LAVI
Correspondent
VILEX, INC.
345 OLD CURRY HOLLOW RD.
PLEASANT HILLS,  PA  15236
Correspondent Contact ABRAHAM LAVI
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received08/11/2005
Decision Date 11/22/2005
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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