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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 K102204
Device Name CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM
Applicant
Choicespine, LP
306 Erin Dr.
Knoxville,  TN  37919
Applicant Contact TODD HAWKINS
Correspondent
Choicespine, LP
306 Erin Dr.
Knoxville,  TN  37919
Correspondent Contact TODD HAWKINS
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received08/05/2010
Decision Date 11/15/2010
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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