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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 K133066
Device Name SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM
Applicant
Spineselect, LLC
13540 Guild Ave.
Apple Valley,  MN  55124
Applicant Contact RICH JANSEN, Pharm.D.
Correspondent
Spineselect, LLC
13540 Guild Ave.
Apple Valley,  MN  55124
Correspondent Contact RICH JANSEN, Pharm.D.
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received09/27/2013
Decision Date 01/13/2014
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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