Vendor/Manufacturer: SpineArt (Meditech)
Product/Product Line: CURE Plate
Vendor/Manufacturer Catalog #: S1-9-00001-37
Global Unique Device (GUD) Primary Device Identifier Number: B167S1900001370
Global Unique Device (GUD) Device Description:
NA
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Spinal fixation plate, non-bioabsorbable
Category 1: Spine
Category 2: Thoracolumbar Plate and Screw System
Category 3: Plate
Category 4: One Level
Quantity of "Each"es needed in each System/Set: 1
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
SUBSTANTIALLY EQUIVALENT to the following products:
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