Medtronic Sofamor Danek ENDOSKELETON TAS NANOLOCK™ Interbody Fusion Devices. Catalog#2307-0211-N

CataBlog
May 11, 2024
2 min read

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: ENDOSKELETON TAS NANOLOCK™

Interbody Fusion System

Vendor/Manufacturer Catalog #: 2307-0211-N

Global Unique Device (GUD) Primary Device Identifier Number:

00191375013846

Global Unique Device (GUD) Device Description:

Interbody Fusion Device 7 Degree Large 11mm

Category 1: Spine

Category 2: Interbody Fusion Devices

Category 3: Lumbar/T-Lumbar

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: OVD

FDA Classification Product Code Device Name:

Intervertebral fusion device with integrated fixation, lumbar

FDA Premarket Submissions: K183557 , K141953 , K173535 , K192018

The Medtronic Sofamor Danek ENDOSKELETON TAS NANOLOCK™

Interbody Fusion Devices are SUBSTANTIALLY EQUIVALENT to the following product(s):

1. HD LifeSciences, LLC Lumbar Interbody System