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FDA 510(k)

CD Horizon Spinal System Instruments

K-Number: K203291 · 2020-12-08

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2020-12-08
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CD Horizon Spinal System Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2020-12-08 under 510(k) number K203291. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CD Horizon Spinal System Instruments?

CD Horizon Spinal System Instruments is a medical device that received FDA 510(k) clearance on 2020-12-08. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K203291.

When did CD Horizon Spinal System Instruments receive FDA 510(k) clearance?

CD Horizon Spinal System Instruments received FDA 510(k) clearance on 2020-12-08, under 510(k) number K203291.

Who is the listed applicant for CD Horizon Spinal System Instruments?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for CD Horizon Spinal System Instruments is OLO.

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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.

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