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Globus Medical CREO® Stabilization System. Catalog #5119.1647

Updated: Jun 26, 2022


Vendor/Manufacturer: Globus Medical

Product/Product Line: CREO® Stabilization System

Vendor/Manufacturer Catalog #: 5119.1647

Global Unique Device (GUD) Primary Device Identifier Number: 00889095104158

Global Unique Device (GUD) Device Description:

CREO® Threaded 6.5 x 45mm Polyaxial Screw


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: 888.3070

FDA Regulation Description Classification Name:

Pedicle Screw Spinal System


FDA Classification Product Code(s): NKB, OSH, KWP, MNH, KWQ, MNI

FDA Classification Product Code Device Name:

NKB: Thoracolumbosacral Pedicle Screw System

OSH: Pedicle screw spinal system, adolescent idiopathic scoliosis

KWP: Appliance, Fixation, Spinal Interlaminal

MNH: Orthosis, spondylolisthesis spinal fixation

KWQ: Appliance, Fixation, Spinal Intervertebral Body

MNI: Orthosis, Spinal Pedicle Fixation


FDA Premarket Submission: K124058


The Globus Medical CREO® Stabilization System is

SUBSTANTIALLY EQUIVALENT to the following products:



For more information, please visit us at Infonomics.com

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