FDA 510(k)

CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)

K-Number: K253941 · 2026-01-07

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2026-01-07

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2026-01-07 under approval number K253941. 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 Spinal System (LigaMAS Head Assembly)?

CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) is a medical device that received FDA 510(k) clearance on 2026-01-07. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K253941.

When was CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) approved by the FDA?

CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) received FDA 510(k) clearance on 2026-01-07, under approval number K253941.

What company makes CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)?

CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)?

The FDA product code for CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) 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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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.