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FDA 510(k)

CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition

K-Number: K182121 · 2018-11-02

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2018-11-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2018-11-02 under approval number K182121. 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 for use with MAZOR X Stealth Edition?

CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K182121.

When was CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition approved by the FDA?

CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition received FDA 510(k) clearance on 2018-11-02, under approval number K182121.

What company makes CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition?

CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition?

The FDA product code for CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition is OLO.

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Related PubMed Literature

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Other Devices by Medtronic Sofamor Danek USA, Inc.

K163301CD HORIZON® Spinal System K162680SOVEREIGN® Spinal System K162379CD HORIZON® Spinal System K162494CD HORIZON® Spinal System K160528ANATOMIC PEEK PTC Cervical Fusion System K160418PERIMETER Interbody Fusion Device

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Related Devices (Code: 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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