Vendor/Manufacturer: Globus Medical
Product/Product Line: CREO® Stabilization System
Vendor/Manufacturer Catalog #: 1119.0010
Global Unique Device (GUD) Primary Device Identifier Number: 00889095059496
Global Unique Device (GUD) Device Description:
Threaded Locking Cap
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):Â KWP, KWQ, MNH, MNI, NKB, OSH
FDA Classification Product Code Device Name:Â
KWP: Appliance, Fixation, Spinal Interlaminal
KWQ: Appliance, Fixation, Spinal Intervertebral Body
MNH: Orthosis, spondylolisthesis spinal fixation
MNI: Orthosis, Spinal Pedicle Fixation
NKB: Thoracolumbosacral Pedicle Screw System
OSH: Pedicle screw spinal system, adolescent idiopathic scoliosis
The Globus Medical CREO® Stabilization System is
SUBSTANTIALLY EQUIVALENT to the following products:
For more information, please visit us at Infonomics.com