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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 K151196
Device Name Nautilus Spinal System
Applicant
LIFE SPINE, INC
13951 S. Quality Drive
Huntley,  IL  60142
Applicant Contact RANDY LEWIS
Correspondent
LIFE SPINE, INC
13951 S. Quality Drive
Huntley,  IL  60142
Correspondent Contact RANDY LEWIS
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI   OSH  
Date Received05/05/2015
Decision Date 07/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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