FDA 510(k)

CD Horizon Astute Spinal System

K-Number: K191066 · 2019-10-03

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2019-10-03

Product CodeNQP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CD Horizon Astute Spinal System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2019-10-03 under approval number K191066. The device is classified under product code NQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CD Horizon Astute Spinal System?

CD Horizon Astute Spinal System is a medical device that received FDA 510(k) clearance on 2019-10-03. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K191066.

When was CD Horizon Astute Spinal System approved by the FDA?

CD Horizon Astute Spinal System received FDA 510(k) clearance on 2019-10-03, under approval number K191066.

What company makes CD Horizon Astute Spinal System?

CD Horizon Astute Spinal System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for CD Horizon Astute Spinal System?

The FDA product code for CD Horizon Astute Spinal System is NQP.

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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: NQP)

K182928CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. K203678CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.

Official Source

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