NuVasive® CoRoent® Small Interlock System. Catalog #6790226

CataBlog
Jul 17, 2022
1 min read

Vendor/Manufacturer: NuVasive®

Product/Product Line: CoRoent® Small Interlock System

Vendor/Manufacturer Catalog #: 6790226

Global Unique Device (GUD) Primary Device Identifier Number: 00887517361615

Global Unique Device (GUD) Device Description:

CoRoent® Small Interlock, 6x17x14mm 7°

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Metallic spinal fusion cage, non-sterile

Global Medical Device Nomenclature (GMDN) Definition:

A non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.

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): ODP

FDA Classification Product Code Device Name(s):

Intervertebral Fusion Device With Bone Graft, Cervical

FDA Premarket Submission(s): K081611 , K192582 , K102547

The NuVasive® CoRoent® Small Interlock System is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Centinel Spine STALIF C System