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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