Steerable Plateau 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 Steerable Plateau Ti.

Pre-market Notification Details

Device IDK193521
510k NumberK193521
Device Name:Steerable Plateau 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
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-19
Decision Date2020-02-06

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