Vendor/Manufacturer: Globus Medical, Inc.
Product/Product Line: CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Right, 13mm
Vendor/Manufacturer Catalog #: 1102.5213
Global Unique Device (GUD) Primary Device Identifier Number:
00193982314729
Global Unique Device (GUD) Device Description:
CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Right, 13mm
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: NQW
FDA Classification Product Code Device Name:
Orthosis, Spine, Plate, Laminoplasty, Metal
FDA Premarket Submissions: K121732
The Globus Medical CANOPY Laminoplasty Fixation System is SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
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