Vendor/Manufacturer: Medtronic Sofamor Danek
Product/Product Line: DIVERGENCE™Anterior Cervical Fusion System
Vendor/Manufacturer Catalog #: G6624015
Global Unique Device (GUD) Primary Device Identifier Number: 00643169338975
Global Unique Device (GUD) Device Description:
SCREW G6624015 NoP S-D 4.0mm x 15mm
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: 888.3080
FDA Regulation Description Classification Name:
Intervertebral Body Fusion Device
FDA Classification Product Code: OVE
FDA Classification Product Code Device Name:
Intervertebral fusion device with integrated fixation, cervical
FDA Premarket Submissions: K141599
The Medtronic Sofamor Danek DIVERGENCE™Anterior Cervical Fusion System is SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
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