Vendor/Manufacturer: Medtronic Sofamor Danek
Product/Product Line: SOVEREIGN Interbody Fusion Device
Vendor/Manufacturer Catalog #: 7975525
Global Unique Device (GUD) Primary Device Identifier Number:
00613994736598
Global Unique Device (GUD) Device Description:
SCREW 7975525 SOVEREIGN FA 5.5 X 25MM
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Orthopaedic bone screw (non-sliding)
Global Medical Device Nomenclature (GMDN) Definition:
A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3080
FDA Regulation Description Classification Name:
Intervertebral Body Fusion Device
FDA Classification Product Code: OVD
FDA Classification Product Code Device Name:
Intervertebral fusion device with integrated fixation, lumbar
The Medtronic Sofamor Danek SOVEREIGN Interbody Fusion Device is
SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
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