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Lumbar Interbody Fusion Cage with VSP Spine System

FDA PMA

Class III (US FDA PMA)

PMA P960025

by Depuy Spine, Inc.

Identity

Trade Name
BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS FDA PMA
Generic Name
Intervertebral fusion device with bone graft, lumbar FDA PMA

Identifiers

PMA Number
P960025 FDA PMA
FDA Product Code
MAX FDA PMA

Classification

Device Class
Class II FDA PMA
Legislation / Framework
21 CFR Part 888.3080 FDA PMA
Regulation Number
888.3080 FDA PMA
Advisory Committee
Orthopedic FDA PMA
FDA Decision
APRL FDA PMA

This device is an intervertebral fusion device with bone graft, lumbar, designed for spinal stabilization. It is intended for use in open posterior surgical approaches to facilitate interbody fusion combined with posterolateral fusion (360-degree fusion) and posterior pedicle screw fixation in patients with degenerative disc disease (DDD) at one or two spinal levels from L2 to S1. The device is approved for use with autogenous bone graft and may be applied in patients who have undergone prior non-fusion spinal surgery at the involved levels.

The Lumbar Interbody Fusion Cage with VSP Spine System is supplied as part of a spinal fixation appliance system, including pedicle screws and plates. It is intended for single-use and requires surgical implantation by a qualified healthcare professional. The device is regulated under an FDA Premarket Approval (PMA) and is classified under product code MAX for orthopedic applications. Sterility and MRI safety specifications are not explicitly detailed in the provided data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Lumbar - Wikipedia, LUMBAR I/F CAGE WITH VSP SPINE SYSTEM PMA P960025S004 - FDA.report, Lumbar Spine: What It Is, Anatomy & Disorders - Cleveland Clinic, Lendenwirbelsäule - DocCheck Flexikon, LUMBAR I/F CAGE WITH VSP SPINE SYSTEM PMA P960025S004 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Depuy Spine, Inc.

Sources (1)

  • FDA PMA P960025 24 fields · synced Oct 6, 2026