AILERON INTERSPINOUS FIXATION SYSTEM

Orthosis, Spinal Pedicle Fixation

LIFE SPINE

The following data is part of a premarket notification filed by Life Spine with the FDA for Aileron Interspinous Fixation System.

Pre-market Notification Details

Device IDK113157
510k NumberK113157
Device Name:AILERON INTERSPINOUS FIXATION SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant LIFE SPINE 2401 Hassell Rd Ste 1535 Hoffman Est,  IL  60169
ContactRandy Lewis
CorrespondentRandy Lewis
LIFE SPINE 2401 Hassell Rd Ste 1535 Hoffman Est,  IL  60169
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-26
Decision Date2012-03-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00190837116248 K113157 000

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