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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 K123623
Device Name ILLICO MIS POSTERIOR FIXATION SYSTEM
Applicant
Alphatec Spine, Inc.
5818 El Camino Real
Carlsnad,  CA  92008
Applicant Contact NADINE SMITH
Correspondent
Alphatec Spine, Inc.
5818 El Camino Real
Carlsnad,  CA  92008
Correspondent Contact NADINE SMITH
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received11/23/2012
Decision Date 02/14/2013
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
Recalls CDRH Recalls
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