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 IDK210549
510k NumberK210549
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  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-25
Decision Date2021-04-22

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