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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 K100407
Device Name LIFE SPINE INTERSPINOUS FIXATION SYSTEM
Original Applicant
LIFE SPINE
2401 w. hassell rd.
suite 1535
hoffman estates,  IL  60169
Original Contact charles p gill
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received02/16/2010
Decision Date 11/05/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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