Medtronic CATALYFT™ PL Expandable Interbody System. Catalog #981027722

CataBlog
Jul 10, 2022
1 min read

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: CATALYFT™ PL Expandable Interbody System

Vendor/Manufacturer Catalog #: 981027722

Global Unique Device (GUD) Primary Device Identifier Number: 00763000465902

Global Unique Device (GUD) Device Description:

SPACER 981027722 6MM ANT EXPANDABLE LG

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): KWQ, MAX

FDA Classification Product Code Device Name(s):

KWQ: Appliance, Fixation, Spinal Intervertebral Body

MAX: 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