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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 K121728
Device Name TIGER SPINE SYSTEM
Applicant
CORELINK LLC
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Applicant Contact J.D. WEBB
Correspondent
CORELINK LLC
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Correspondent Contact J.D. WEBB
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received06/12/2012
Decision Date 10/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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