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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 Bone Graft, Cervical
510(k) Number K160154
Device Name ALTA Anterior Cervical Interbody Spacer
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 Number888.3080
Classification Product Code
ODP  
Date Received01/20/2016
Decision Date 05/13/2016
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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