ProLift Expandable System

Intervertebral Fusion Device With Bone Graft, Lumbar

LIFE SPINE, INC.

The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Prolift Expandable System.

Pre-market Notification Details

Device IDK153400
510k NumberK153400
Device Name:ProLift Expandable System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant LIFE SPINE, INC. 13951 S QUALITY DRIVE Huntley,  IL  60142
ContactRandy Lewis
CorrespondentRandy Lewis
LIFE SPINE, INC. 13951 S QUALITY DRIVE Huntley,  IL  60142
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-24
Decision Date2016-03-07
Summary:summary

NIH GUDID Devices

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