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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 K103383
Device Name SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
Applicant
Spartek Medical, Inc.
1100 Marina Villiage Pkwy.
Suite 103
Alameda,  CA  94501
Applicant Contact HENRY KLYCE
Correspondent
Spartek Medical, Inc.
1100 Marina Villiage Pkwy.
Suite 103
Alameda,  CA  94501
Correspondent Contact HENRY KLYCE
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received11/18/2010
Decision Date 02/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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