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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 K203056
Device Name Invictus™ Spinal Fixation System
Applicant
Alphatec Spine, Inc.
5818 E1 Camino Real
Carlsbad,  CA  92008
Applicant Contact Cynthia Dorne
Correspondent
Alphatec Spine, Inc.
5818 E1 Camino Real
Carlsbad,  CA  92008
Correspondent Contact Cynthia Dorne
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received10/08/2020
Decision Date 11/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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