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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K080502
Device Name MODIFICATION TO:PILOT SPINAL SYSTEM
Applicant
LIFE SPINE
2401 W. HASSELL RD.
SUITE 1535
HOFFMAN ESTATES,  IL  60169
Applicant Contact REBECCA M BROOKS
Correspondent
LIFE SPINE
2401 W. HASSELL RD.
SUITE 1535
HOFFMAN ESTATES,  IL  60169
Correspondent Contact REBECCA M BROOKS
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received02/25/2008
Decision Date 04/08/2008
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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