Globus Medical COALITION AGX Interbody Fusion Device. Catalog #1128.1507

Vendor/Manufacturer: Globus Medical

Product/Product Line: COALITION AGX Interbody Fusion Device

Vendor/Manufacturer Catalog #: 1128.1507

Global Unique Device (GUD) Primary Device Identifier Number: 

00889095070637

Global Unique Device (GUD) Device Description: 

COALITION AGX Plate, 18mm W, 7mm H

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Spinal fixation plate, non-bioabsorbable

Global Medical Device Nomenclature (GMDN) Definition:

A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

FDA Regulation Medical Specialty: 

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3060

FDA Regulation Description Classification Name: 

Spinal intervertebral body fixation orthosis

FDA Classification Product Code: KWQ

FDA Classification Product Code Device Name: 

Appliance, Fixation, Spinal Intervertebral Body

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

2. VIP® Anterior Cervical Plate System 

3. InterPlate™ C

4. IN:C2™ Spinal Fixation System

5. PEEK Prevail® Cervical Interbody Device 

6. PATRIOT® Colonial® ACDF Spacer

7. COALITION® Spacer

8. PATRIOT Cervical Spacer

9. COLONIAL ACDF Spacer

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