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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 K072116
Device Name SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM
Applicant
Neurospine Innovations and Solutions
13540 Guild Ave.
Apple Valley,  MN  55124
Applicant Contact RICHARD JANSEN
Correspondent
Neurospine Innovations and Solutions
13540 Guild Ave.
Apple Valley,  MN  55124
Correspondent Contact RICHARD JANSEN
Regulation Number888.3070
Classification Product Code
NKB  
Date Received08/01/2007
Decision Date 03/20/2008
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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