Globus Medical COALITION AGX Interbody Fusion Device. Catalog #184.154

CataBlog
Dec 21, 2020
1 min read

Updated: May 13, 2024

Vendor/Manufacturer: Globus Medical

Product/Product Line: COALITION AGX Interbody Fusion Device

Vendor/Manufacturer Catalog #: 184.154

Global Unique Device (GUD) Primary Device Identifier Number:

00849044007725

Global Unique Device (GUD) Device Description:

3.6mm Bone Screw, Variable, Self-Drilling, 14mm

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Metallic spinal interbody fusion cage

Global Medical Device Nomenclature (GMDN) Definition:

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3080

FDA Regulation Description Classification Name:

Intervertebral body fusion device

FDA Classification Product Code: ODP

FDA Classification Product Code Device Name:

Intervertebral fusion device with bone graft, cervical

FDA Premarket Submissions: K142218, K083389

The Globus Medical COALITION AGX Interbody Fusion Device is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. SUSTAIN® Radiolucent Medium