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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 K150211
Device Name EzFuze Implant System
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 Number888.3040
Classification Product Code
HWC  
Date Received01/30/2015
Decision Date 11/10/2015
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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