LongBow Ti

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 Longbow Ti.

Pre-market Notification Details

Device IDK190721
501k NumberK190721
Device Name:LongBow Ti
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Life Spine Inc. 13951 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)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-20
Decision Date2019-11-14

NIH GUDID Devices

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