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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name posterior cervical screw system
510(k) Number K200936
Device Name Invictus™ CT Spinal Fixation System
Applicant
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad,  CA  92008
Applicant Contact Ruby Zheng
Correspondent
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad,  CA  92008
Correspondent Contact Ruby Zheng
Regulation Number888.3075
Classification Product Code
NKG  
Date Received04/08/2020
Decision Date 05/22/2020
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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