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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 K113058
Device Name TIGER SPINE SYSTEM
Applicant
Corelink, LLC
1331 H St.
12th Floor
Washington,  DC  20005
Applicant Contact JUSTIN EGGLETON
Correspondent
Corelink, LLC
1331 H St.
12th Floor
Washington,  DC  20005
Correspondent Contact JUSTIN EGGLETON
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received10/14/2011
Decision Date 03/29/2012
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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