Globus Medical COALITION MIS Spacer. Catalog #1136.5878

Vendor/Manufacturer: Globus Medical, Inc.

Product/Product Line: COALITION MIS® Spacer

Vendor/Manufacturer Catalog #: 1136.5878

Global Unique Device (GUD) Primary Device Identifier Number:

00889095304442

Global Unique Device (GUD) Device Description:

COALITION MIS Spacer, Ti 15 x 18, 7°, 8mm

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: OVE

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Integrated Fixation, Cervical

FDA Premarket Submissions: K151939

The Globus Medical COALITION MIS Spacer is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. LDR Spine ROI-C Implant

2. Centinel Spine STALIF C

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