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FDA 510(k)

CD Horizon Spinal System

K-Number: K211596 · 2021-06-23

ApplicantMedtronic
Decision Date2021-06-23
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CD Horizon Spinal System is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2021-06-23 under approval 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. It is manufactured by Medtronic. The 510(k) number is K211596.

When was CD Horizon Spinal System approved by the FDA?

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

What company makes CD Horizon Spinal System?

CD Horizon Spinal System is manufactured by Medtronic.

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.