GX Navigation Instrument System

Orthopedic Stereotaxic Instrument

Life Spine Inc.

The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Gx Navigation Instrument System.

Pre-market Notification Details

Device IDK202836
510k NumberK202836
Device Name:GX Navigation Instrument System
ClassificationOrthopedic Stereotaxic Instrument
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 CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-25
Decision Date2021-08-19

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