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Velofix SA Cervical Cage

by U&I Corporation 510(k)

Active United States

510(k) K172424

Overview

The Velofix SA Cervical Cage is an orthopedic device designed for use in cervical spine surgery. It is a cage implant intended to be placed between vertebrae to facilitate fusion and provide structural support.

The device is supplied as a single-use implant and is not MRI safe. It is manufactured by U&I Corporation in South Korea and has received FDA 510(k) clearance with the product code OVE. The device is available in various sizes as indicated by the model number K172424.

AI-generated from registry data, 23 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 NumberK172424 Date22 Nov 2017ClearedStatusActive

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
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1823-2020 FDA Class II initiated 30 Jan 2019

    The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians.

Specification

510(k)

510(k) Number
FDA Product Code
OVE
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from U&I Corp.

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Questions

  • What is the Velofix SA Cervical Cage used for?

    The Velofix SA Cervical Cage is an orthopedic device designed for cervical spine surgery. It is implanted between vertebrae to facilitate fusion and provide structural support to the cervical spine.

  • Is the Velofix SA Cervical Cage reusable or MRI safe?

    The Velofix SA Cervical Cage is supplied as a single-use implant and is not MRI safe. It should only be used once and cannot be used in MRI environments due to its material composition.

  • What sizes and models are available for the Velofix SA Cervical Cage?

    The Velofix SA Cervical Cage is available in various sizes as indicated by the model number K172424. Different sizes are provided to accommodate various patient anatomies and surgical requirements.

  • What is the regulatory status of the Velofix SA Cervical Cage?

    The Velofix SA Cervical Cage has received FDA 510(k) clearance with the product code OVE. It is manufactured by U&I Corporation in South Korea and was cleared as substantially equivalent to predicate devices.