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FDA 510(k)

ARx Spinal System

K-Number: K210549 · 2021-04-22

ApplicantLife Spine, Inc.
Decision Date2021-04-22
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARx Spinal System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2021-04-22 under approval number K210549. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARx Spinal System?

ARx Spinal System is a medical device that received FDA 510(k) clearance on 2021-04-22. It is manufactured by Life Spine, Inc.. The 510(k) number is K210549.

When was ARx Spinal System approved by the FDA?

ARx Spinal System received FDA 510(k) clearance on 2021-04-22, under approval number K210549.

What company makes ARx Spinal System?

ARx Spinal System is manufactured by Life Spine, Inc..

What is the FDA product code for ARx Spinal System?

The FDA product code for ARx Spinal System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Life Spine, Inc.

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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