ChoiceSpine Harrier™ SA Anterior Lumbar Interbody Fusion System. Catalog #Y070-0036

Vendor/Manufacturer: ChoiceSpine

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

Vendor/Manufacturer Catalog #: Y070-0036

Global Unique Device (GUD) Primary Device Identifier Number: 00840996174565

Global Unique Device (GUD) Device Description:

HARRIER-SA, MALLET

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Intervertebral-body internal spinal fixation system

Global Medical Device Nomenclature (GMDN) Definition:

A group of sterile implantable devices designed to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The system components are typically made of medical grade titanium and consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the centre of each plate, and a braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and is fastened or crimped at each eye-type screw.

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 Classification Product Code: MAX

FDA Classification Product Code Device Name:

Intervertebral fusion device with bone graft, 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

3. Choice Spine TOMCAT Cervical Spinal System

4. Choice Spine TiGer Shark

For more information, please visit us at Infonomics.com