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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, Spinal Intervertebral Body
510(k) Number K130030
Device Name ZAVATION CERVICAL PLATE SYSTEM
Applicant
Zavation, LLC
501 Avalon Way
Brandon,  MS  39047
Applicant Contact JOHN WALKER
Correspondent
Zavation, LLC
501 Avalon Way
Brandon,  MS  39047
Correspondent Contact JOHN WALKER
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received01/04/2013
Decision Date 04/25/2013
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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