ProLift Lateral HELO Fixated

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 Lateral Helo Fixated.

Pre-market Notification Details

Device IDK210061
510k NumberK210061
Device Name:ProLift Lateral HELO Fixated
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Life Spine, Inc. 139541 S. Quality Drive Huntley,  IL  60142
ContactAngela Batker
CorrespondentAngela Batker
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 Received2021-01-11
Decision Date2021-04-30

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