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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, thoracic
510(k) Number K180480
Device Name ATEC Universal Spacer System
Applicant
Alphatec Spine, Inc
5818 El Camino Real
Carlsbad,  CA  92008
Applicant Contact Jeremy Markovich
Correspondent
Alphatec Spine, Inc
5818 El Camino Real
Carlsbad,  CA  92008
Correspondent Contact Jeremy Markovich
Regulation Number888.3080
Classification Product Code
PHM  
Subsequent Product Code
MAX  
Date Received02/23/2018
Decision Date 05/31/2018
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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