Vendor/Manufacturer: Medtronic Sofamor Danek
Product/Product Line: CATALYFT™ PL Expandable Interbody System
Vendor/Manufacturer Catalog #: 6068076
Global Unique Device (GUD) Primary Device Identifier Number: 00763000246709
Global Unique Device (GUD) Device Description:
SPACER 6068076 CATALYFT PL LONG 7MM
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Metallic spinal interbody fusion cage
Global Medical Device Nomenclature (GMDN) Definition:
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
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(s): MAX
FDA Classification Product Code Device Name(s):
Intervertebral fusion device with bone graft, lumbar
FDA Premarket Submission: K210425 , K212653 The Medtronic Sofamor Danek CATALYFT™ PL Expandable Interbody System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Artic-L™ 3D Ti Spinal System 2. Artic-XL™ 3D Ti Spinal System 3. Elevate™ Spinal System 4. Crescent™ Spinal System 5. Clydesdale™ Spinal System
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