Vendor/Manufacturer: Globus Medical
Product/Product Line: PLYMOUTH Thoracolumbar Plate System
Vendor/Manufacturer Catalog #: 1105.3013
Global Unique Device (GUD) Primary Device Identifier Number:
00889095028225
Global Unique Device (GUD) Device Description:
PLYMOUTH Thoracolumbar Plate, L4-L5, 19mm
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Spinal fixation plate, non-bioabsorbable
Global Medical Device Nomenclature (GMDN) Definition:
A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).
Category 1: Spine
Category 2: Thoracolumbar Plate and Screw System
Category 3: Plate
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3060
FDA Regulation Description Classification Name:
Spinal intervertebral body fixation orthosis
FDA Classification Product Code: KWQ
FDA Classification Product Code Device Name:
Appliance, Fixation, Spinal Intervertebral Body
The Globus Medical PLYMOUTH Thoracolumbar Plate System is
SUBSTANTIALLY EQUIVALENT to the following products:
For more information, please visit us at Infonomics.com
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