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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 K202587
Device Name ATEC Lateral Interbody System
Applicant
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad,  CA  92008
Applicant Contact Sandy Gill
Correspondent
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad,  CA  92008
Correspondent Contact Sandy Gill
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
OVD   PHM  
Date Received09/08/2020
Decision Date 11/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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