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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K141937
Device Name TRIDENT FUSION IMPLANT
Applicant
Vilex IN Tennessee, Inc.
8374 Market St., #167
Lakewood Ranch,  FL  34202
Applicant Contact ABRAHAM LAVI
Correspondent
Vilex IN Tennessee, Inc.
8374 Market St., #167
Lakewood Ranch,  FL  34202
Correspondent Contact ABRAHAM LAVI
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/17/2014
Decision Date 09/10/2014
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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