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FDA 510(k)

MODIFICATION TO:CD HORIZON SPINAL SYSTEM

K-Number: K052747 · 2005-10-28

ApplicantMedtronic Sofamor Danek
Decision Date2005-10-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:CD HORIZON SPINAL SYSTEM 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 2005-10-28 under 510(k) number K052747. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO:CD HORIZON SPINAL SYSTEM?

MODIFICATION TO:CD HORIZON SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-28. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K052747.

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

MODIFICATION TO:CD HORIZON SPINAL SYSTEM received FDA 510(k) clearance on 2005-10-28, under 510(k) number K052747.

Who is the listed applicant for MODIFICATION TO:CD HORIZON SPINAL SYSTEM?

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 MODIFICATION TO:CD HORIZON SPINAL SYSTEM?

The FDA product code for MODIFICATION TO:CD HORIZON SPINAL SYSTEM is NKB.

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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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