NuVasive® MODULUS Interbody Fusion. Catalog #1225050P2

Vendor/Manufacturer: NuVasive®

Product/Product Line: MODULUS Interbody Fusion

Vendor/Manufacturer Catalog #: 1225050P2

Global Unique Device (GUD) Primary Device Identifier Number:

00887517726841

Global Unique Device (GUD) Device Description:

Modulus XLW, 10x22x50mm 15°

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(s): MAX, PHM

FDA Classification Product Code Device Name:

MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

PHM: Intervertebral fusion device with bone graft, thoracic

FDA Premarket Submissions: K163230

The NuVasive® MODULUS Interbody Fusion Device is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Stryker Spine Tritanium PL® Cage

2. K2M CASCADIA Interbody System

3. CoRoent® Lumbar Interbody Implants

4. CoRoent System

5. CoRoent Ti-C System

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