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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K141005
Device Name Z-LINK CERVICAL
Applicant
Zavation, LLC
400 Liberty Park
Flowood,  MS  39232
Applicant Contact JOHN WALKER
Correspondent
Zavation, LLC
400 Liberty Park
Flowood,  MS  39232
Correspondent Contact JOHN WALKER
Regulation Number888.3080
Classification Product Code
OVE  
Date Received04/18/2014
Decision Date 08/07/2014
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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