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FDA 510(k)

ARCUATE VERTEBRAL AUGMENTATION SYSTEM

K-Number: K063248 · 2007-03-13

ApplicantMedtronic Sofamor Danek
Decision Date2007-03-13
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARCUATE VERTEBRAL AUGMENTATION 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 2007-03-13 under 510(k) number K063248. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCUATE VERTEBRAL AUGMENTATION SYSTEM?

ARCUATE VERTEBRAL AUGMENTATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-13. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K063248.

When did ARCUATE VERTEBRAL AUGMENTATION SYSTEM receive FDA 510(k) clearance?

ARCUATE VERTEBRAL AUGMENTATION SYSTEM received FDA 510(k) clearance on 2007-03-13, under 510(k) number K063248.

Who is the listed applicant for ARCUATE VERTEBRAL AUGMENTATION 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 ARCUATE VERTEBRAL AUGMENTATION SYSTEM?

The FDA product code for ARCUATE VERTEBRAL AUGMENTATION SYSTEM is NDN.

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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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