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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 K141222
Device Name NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM
Applicant
LIFE SPINE, INC
2401 W. HASSELL RD SUITE 1535
HOFFMAN ESTATES,  IL  60169
Applicant Contact RANDY LEWIS
Correspondent
LIFE SPINE, INC
13951 South Quality Drive
Huntley,  IL  60142
Correspondent Contact RANDY LEWIS
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received05/12/2014
Decision Date 02/12/2015
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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