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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 K160702
Device Name ZION Anterior Cervical Fixation System
Applicant
Astura Medical
5670 El Camino Real
Suite B
Carlsbad,  CA  92008
Applicant Contact TROY TAYLOR
Correspondent
The OrthoMedix Group, Inc.
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J.D WEBB
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/14/2016
Decision Date 08/23/2016
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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