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Velofix Interbody Fusion System

by U&I Corporation 510(k)

Active United States

510(k) K171749

Overview

The Velofix Interbody Fusion System is an interbody fusion system consisting of PEEK-OPTIMA cervical and lumbar cages, used to facilitate spinal fusion in conjunction with autograft and supplemental fixation. The implants feature open architecture for bone graft packing and tantalum markers for radiographic visualization. This system is designed for intervertebral body fusion and provides structural support to the disc space, facilitating fusion in patients.

The Velofix Interbody Fusion System is implanted via an anterior approach and requires supplemental fixation. It is available with FDA 510K authorization, specifically with the clearance number K171749. The system is supplied in various sizes, including cervical and lumbar cages, and is intended for use in spinal fusion procedures.

AI-generated from registry data, 25 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 NumberK171749 Date13 Jul 2017ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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)

Full name
Velofix(tm) Interbody Fusion System
510(k) Number
FDA Product Code
ODP
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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