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FDA 510(k)

CD HORIZON SPIRE Z SPINAL SYSTEM

K-Number: K123246 · 2012-11-16

ApplicantMedtronic Sofamor Danek
Decision Date2012-11-16
Product CodeNKB
Advisory CommitteeOR
DecisionUnknown

Device Summary

CD HORIZON SPIRE Z 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 2012-11-16 under 510(k) number K123246. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CD HORIZON SPIRE Z SPINAL SYSTEM?

CD HORIZON SPIRE Z SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-16. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K123246.

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

CD HORIZON SPIRE Z SPINAL SYSTEM received FDA 510(k) clearance on 2012-11-16, under 510(k) number K123246.

Who is the listed applicant for CD HORIZON SPIRE Z 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 CD HORIZON SPIRE Z SPINAL SYSTEM?

The FDA product code for CD HORIZON SPIRE Z 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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