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FDA 510(k)

AVAFLEX VERTEBRAL AUGMENTATION NEEDLE

K-Number: K072133 · 2007-11-20

ApplicantCardinal Health, Inc.
Decision Date2007-11-20
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AVAFLEX VERTEBRAL AUGMENTATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Inc.. It received FDA 510(k) clearance on 2007-11-20 under 510(k) number K072133. 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 AVAFLEX VERTEBRAL AUGMENTATION NEEDLE?

AVAFLEX VERTEBRAL AUGMENTATION NEEDLE is a medical device that received FDA 510(k) clearance on 2007-11-20. The listed applicant is Cardinal Health, Inc.. The 510(k) number is K072133.

When did AVAFLEX VERTEBRAL AUGMENTATION NEEDLE receive FDA 510(k) clearance?

AVAFLEX VERTEBRAL AUGMENTATION NEEDLE received FDA 510(k) clearance on 2007-11-20, under 510(k) number K072133.

Who is the listed applicant for AVAFLEX VERTEBRAL AUGMENTATION NEEDLE?

The FDA 510(k) record lists Cardinal Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVAFLEX VERTEBRAL AUGMENTATION NEEDLE?

The FDA product code for AVAFLEX VERTEBRAL AUGMENTATION NEEDLE 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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