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FDA 510(k)

CD HORIZON® Spinal System

K-Number: K162494 · 2016-10-04

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2016-10-04
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CD HORIZON® Spinal System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-10-04 under approval number K162494. 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 CD HORIZON® Spinal System?

CD HORIZON® Spinal System is a medical device that received FDA 510(k) clearance on 2016-10-04. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K162494.

When was CD HORIZON® Spinal System approved by the FDA?

CD HORIZON® Spinal System received FDA 510(k) clearance on 2016-10-04, under approval number K162494.

What company makes CD HORIZON® Spinal System?

CD HORIZON® Spinal System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for CD HORIZON® Spinal System?

The FDA product code for CD HORIZON® Spinal System is NKB.

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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 Medtronic Sofamor Danek USA, Inc.

K163301CD HORIZON® Spinal System K162680SOVEREIGN® Spinal System K162379CD HORIZON® Spinal System K160528ANATOMIC PEEK PTC Cervical Fusion System K160418PERIMETER Interbody Fusion Device K153438PERIMETER C (Titanium) Spinal System

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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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