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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 K072672
Device Name SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES
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  
Subsequent Product Codes
MNH   MNI  
Date Received09/21/2007
Decision Date 11/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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