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FDA 510(k)

CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)

K-Number: K032037 · 2003-09-04

ApplicantMedtronic Sofamor Danek
Decision Date2003-09-04
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2003-09-04 under 510(k) number K032037. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)?

CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) is a medical device that received FDA 510(k) clearance on 2003-09-04. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K032037.

When did CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) receive FDA 510(k) clearance?

CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) received FDA 510(k) clearance on 2003-09-04, under 510(k) number K032037.

Who is the listed applicant for CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)?

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

What is the FDA product code for CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)?

The FDA product code for CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) is MNI.

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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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