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Velofixtm Interbody Fusion System

by U&I Corp. 510(k)

Active United States

510(k) K132926

Overview

The Velofix Interbody Fusion System is a spinal implant designed for cervical and lumbar interbody fusion. It consists of polyether-ether-ketone (PEEK) cages with an open architecture to facilitate bone graft placement and tantalum markers for radiographic visualization, enabling precise surgical alignment and fusion assessment.

This system is supplied as a sterile, single-use device intended for surgical use in spinal fusion procedures. The cervical cages are implanted via an anterior approach, while lumbar cages are inserted through posterior (PLIF) or transforaminal (TLIF) techniques. Authorized under FDA 510(k) clearance (K132926) as substantially equivalent, the device adheres to orthopedic product standards and is classified under product code ODP.

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 NumberK132926 Date5 Mar 2014ClearedStatusActive

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  • Withdrawn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)

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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