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FDA 510(k)

AVAMAX VERTEBRAL BALLOON

K-Number: K103064 · 2011-01-10

ApplicantCare Fusion
Decision Date2011-01-10
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AVAMAX VERTEBRAL BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2011-01-10 under 510(k) number K103064. 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 AVAMAX VERTEBRAL BALLOON?

AVAMAX VERTEBRAL BALLOON is a medical device that received FDA 510(k) clearance on 2011-01-10. The listed applicant is Care Fusion. The 510(k) number is K103064.

When did AVAMAX VERTEBRAL BALLOON receive FDA 510(k) clearance?

AVAMAX VERTEBRAL BALLOON received FDA 510(k) clearance on 2011-01-10, under 510(k) number K103064.

Who is the listed applicant for AVAMAX VERTEBRAL BALLOON?

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

What is the FDA product code for AVAMAX VERTEBRAL BALLOON?

The FDA product code for AVAMAX VERTEBRAL BALLOON 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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