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FDA 510(k)

CD HORIZON SPINAL SYSTEM

K-Number: K010249 · 2001-02-23

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2001-02-23
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CD HORIZON SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek, Inc.. It received FDA 510(k) clearance on 2001-02-23 under 510(k) number K010249. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. 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 2001-02-23. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K010249.

When did CD HORIZON SPINAL SYSTEM receive FDA 510(k) clearance?

CD HORIZON SPINAL SYSTEM received FDA 510(k) clearance on 2001-02-23, under 510(k) number K010249.

Who is the listed applicant for CD HORIZON SPINAL SYSTEM?

The FDA 510(k) record lists Medtronic Sofamor Danek, Inc. 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 MNH. This falls under the ENT category.

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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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