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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 K132760
Device Name NAUTILUS SPINAL SYSTEM
Applicant
LIFE SPINE, INC
2401 W. HASSELL RD SUITE 1535
HOFFMAN ESTATES,  IL  60169
Applicant Contact RANDY LEWIS
Correspondent
LIFE SPINE, INC
2401 W. HASSELL RD SUITE 1535
HOFFMAN ESTATES,  IL  60169
Correspondent Contact RANDY LEWIS
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received09/04/2013
Decision Date 10/03/2013
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
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