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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K033090
Device Name ICON POLYAXIAL PEDICLE SCREW SYSTEM
Applicant
ALPHATEC MFG., INC.
6110 CORTE DEL CEDRO
CARLSBAD,  CA  92009
Applicant Contact ELLEN A HICKS
Correspondent
ALPHATEC MFG., INC.
6110 CORTE DEL CEDRO
CARLSBAD,  CA  92009
Correspondent Contact ELLEN A HICKS
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received09/29/2003
Decision Date 03/26/2004
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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