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Avamax Vertebral Balloon

by Care Fusion 510(k)

Active United States

510(k) K103064

Overview

The AVAMAX VERTEBRAL BALLOON is an inflatable bone tamp used in balloon kyphoplasty. It consists of a balloon catheter designed to be inserted into the vertebral body under imaging guidance to create a cavity in cancellous bone.

The device is supplied as a single-use, sterile balloon catheter intended for use in vertebral augmentation procedures. It is regulated under FDA 510(k) clearance (K103064) and is indicated for creating a cavity in vertebral bone prior to cement delivery, as described in the device specifications and procedure guidance.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103064 Date10 Jan 2011ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
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  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NDN
Device Class
Class II
Regulation
21 CFR Part 888.3027
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the AVAMAX VERTEBRAL BALLOON used for?

    The AVAMAX VERTEBRAL BALLOON is an inflatable bone tamp used in balloon kyphoplasty to create a cavity in cancellous bone within the vertebral body under imaging guidance, prior to cement delivery, as specified in the device description.

  • How is the AVAMAX VERTEBRAL BALLOON supplied and is it reusable?

    The device is supplied as a single-use, sterile balloon catheter, meaning it is intended for one-time use only and must not be reused, as explicitly stated in the description.

  • What regulatory pathway was used for the AVAMAX VERTEBRAL BALLOON?

    The AVAMAX VERTEBRAL BALLOON received FDA 510(k) clearance under K103064, indicating it was found substantially equivalent to a predicate device through the traditional 510(k) process.

  • What is the product code and device class for the AVAMAX VERTEBRAL BALLOON?

    The device is classified under product code NDN and is a Class II medical device, as indicated by the openfda field showing device_class=2 and the product_code field listing NDN.