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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 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 2018-11-02 under 510(k) 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. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K182121.

When did CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition receive FDA 510(k) clearance?

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

Who is the listed applicant for CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition?

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 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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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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