FDA 510(k)

CD Horizon Spinal System

K-Number: K211596 · 2021-06-23

Decision Date2021-06-23

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CD Horizon Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2021-06-23 under 510(k) number K211596. 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?

CD Horizon Spinal System is a medical device that received FDA 510(k) clearance on 2021-06-23. The listed applicant is Medtronic. The 510(k) number is K211596.

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

CD Horizon Spinal System received FDA 510(k) clearance on 2021-06-23, under 510(k) number K211596.

Who is the listed applicant for CD Horizon Spinal System?

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

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

The FDA product code for CD Horizon Spinal System 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.