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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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