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Pathway IVB/VBR

by Custom Spine, Inc. 510(k)

Active United States

510(k) K092904

Overview

The Pathway IVB/VBR is an intervertebral fusion device with bone graft, cervical, classified under product code ODP. It is designed for use in orthopedic procedures to facilitate intervertebral body fusion in the cervical spine.

The device is supplied by Custom Spine, Inc. and received FDA 510(k) clearance on December 22, 2009, with a decision of substantially equivalent. It is regulated under 21 CFR 888.3080 and is classified as a class II device for orthopedic use.

AI-generated from registry data, 24 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 NumberK092904 Date22 Dec 2009ClearedStatusActive

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

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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Questions

  • What is the Pathway IVB/VBR device used for?

    The Pathway IVB/VBR is an intervertebral fusion device designed for orthopedic procedures to facilitate intervertebral body fusion specifically in the cervical spine region.

  • How is the Pathway IVB/VBR device supplied?

    The device is supplied by Custom Spine, Inc. and includes bone graft material to support the fusion process during cervical spine procedures.

  • What is the regulatory status of the Pathway IVB/VBR?

    The Pathway IVB/VBR received FDA 510(k) clearance on December 22, 2009, with a determination of substantial equivalence. It is classified as a class II device under product code ODP and regulated under 21 CFR 888.3080.

  • Is the Pathway IVB/VBR device reusable or single-use?

    The device data does not specify whether the Pathway IVB/VBR is designed for single-use or multiple uses. This information should be obtained directly from the manufacturer or product documentation.