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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, Lumbar
510(k) Number K191311
Device Name ATEC Lateral Interbody System
Applicant
Alphatec Spine, Inc.
5818 El Camino Real
Carlsnad,  CA  92008
Applicant Contact Cynthia Adams
Correspondent
Alphatec Spine, Inc.
5818 El Camino Real
Carlsnad,  CA  92008
Correspondent Contact Cynthia Adams
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
OVD   PHM  
Date Received05/15/2019
Decision Date 08/12/2019
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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