FDA 510(k)

CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System

K-Number: K260216 · 2026-04-21

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2026-04-21

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2026-04-21 under approval number K260216. 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 ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System?

CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System is a medical device that received FDA 510(k) clearance on 2026-04-21. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K260216.

When was CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System approved by the FDA?

CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System received FDA 510(k) clearance on 2026-04-21, under approval number K260216.

What company makes CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System?

CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System?

The FDA product code for CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX 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)

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Related Devices (Code: NKB)

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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.