ChoiceSpine Harrier™ SA Anterior Lumbar Interbody Fusion System. Catalog #Y070-0040

CataBlog
Jun 5, 2022
1 min read

Vendor/Manufacturer: ChoiceSpine

Product/Product Line: Harrier™ SA Anterior Lumbar Interbody Fusion System

Vendor/Manufacturer Catalog #: Y070-0040

Global Unique Device (GUD) Primary Device Identifier Number: 00840996177399

Global Unique Device (GUD) Device Description:

HARRIER-SA, TRIAL, STARTER

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: OVD

FDA Classification Product Code Device Name:

Intervertebral fusion device with integrated fixation, lumbar

FDA Premarket Submission: K180519

The ChoiceSpine Harrier™ SA Anterior Lumbar Interbody Fusion System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Spine Smith Cynch Spinal System – Visualif Interbody Fusion Implant System

2. NuVasive Lumbar Interbody Implants