Globus Medical QUARTEX™ Occipito-Cervico-Thoracic Spinal System. Catalog #1149.1900

Vendor/Manufacturer: Globus Medical

Product/Product Line: QUARTEX™ Occipito-Cervico-Thoracic Spinal System

Vendor/Manufacturer Catalog #: 1149.1900

Global Unique Device (GUD) Primary Device Identifier Number: 00889095358193

Global Unique Device (GUD) Device Description:

QUARTEX Inline Hook

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Trans-facet-screw internal spinal fixation system, sterile

Global Medical Device Nomenclature (GMDN) Definition:

A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3050

FDA Regulation Description Classification Name:

Spinal interlaminal fixation orthosis

FDA Classification Product Code: KWP , NKG

FDA Classification Product Code Device Name:

KWP: Appliance, Fixation, Spinal Interlaminal

NKG: Posterior cervical screw system

FDA Premarket Submission: K161591

The Globus Medical QUARTEX™ Occipito-Cervico-Thoracic Spinal System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. ELLIPSE® OCT Spinal System

2. PROTEX® CT OCT Spinal System

3. Synapse OCT System

4. H-LINK™ Integrated Rod

5. Globus Navigation Instruments

For more information, please visit us at Infonomics.com