ARx Spinal System

Thoracolumbosacral Pedicle Screw System

Life Spine Inc.

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

Pre-market Notification Details

Device IDK200070
510k NumberK200070
Device Name:ARx Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
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 CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-13
Decision Date2020-04-23

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