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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K181677
Device Name Kodiak Spinal Fixation 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 Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received06/26/2018
Decision Date 08/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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