Vendor/Manufacturer: Medtronic Sofamor Danek
Product/Product Line: ATLANTIS® Anterior Cervical Plate System
Vendor/Manufacturer Catalog #: 3125515
Global Unique Device (GUD) Primary Device Identifier Number: 00613994241252
Global Unique Device (GUD) Device Description:
SCREW 3125515 4.5 X 15 SELF DRILL VAR
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Spinal bone screw, non-bioabsorbable
Global Medical Device Nomenclature (GMDN) Definition:
A small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; 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 available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.
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
FDA Premarket Submissions: K063100
The Medtronic Sofamor Danek ATLANTIS® Anterior Cervical Plate System is
SUBSTANTIALLY EQUIVALENT to the following products:
For more information, please visit us at Infonomics.com
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