FDA 510(k) Application Details - K140236

Device Classification Name

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510(K) Number K140236
Device Name AILERON INTERSPINOUS FIXATION SYSTEM
Applicant LIFE SPINE, INC
2401 W. HASSELL RD SUITE 1535
HOFFMAN ESTATES, IL 60169 US
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Contact RANDY LEWIS
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Regulation Number

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Classification Product Code PEK
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Date Received 01/30/2014
Decision Date 10/20/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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