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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 K082032
Device Name SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)
Applicant
ABBOTT SPINE, INC.
5301 RIATA PARK CT., BLDG. F
AUSTIN,  TX  78727
Applicant Contact DAVID PADGETT
Correspondent
ABBOTT SPINE, INC.
5301 RIATA PARK CT., BLDG. F
AUSTIN,  TX  78727
Correspondent Contact DAVID PADGETT
Regulation Number888.3070
Classification Product Code
NKB  
Date Received07/17/2008
Decision Date 10/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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