ChoiceSpine RAVEN™ Anterior Lumbar Plate System. Catalog #Y070-1008

Vendor/Manufacturer: ChoiceSpine

Product/Product Line: RAVEN™ Anterior Lumbar Plate System

Vendor/Manufacturer Catalog #: Y070-1008

Global Unique Device (GUD) Primary Device Identifier Number: 00840996177146

Global Unique Device (GUD) Device Description:

STRAIGHT DRIVER LUMBAR PLATE SYSTEM

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Spinal fixation plate, non-bioabsorbable

Global Medical Device Nomenclature (GMDN) Definition:

A small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3060

FDA Regulation Description Classification Name:

Spinal intervertebral body fixation orthosis

FDA Classification Product Code: LXH

FDA Classification Product Code Device Name:

Orthopedic Manual Surgical Instrument

FDA Premarket Submission: K183214

The ChoiceSpine RAVEN™ Anterior Lumbar Plate System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Stryker Spine LITe® Plate System

2. Corelink Zou Anterior Lumbar Plate System

3. Meditech Spine Cure Lumbar Plate System

4. Altiva Corporation Altes Anterior Buttress Plating System

5. Globus Plymouth Thoracolumbar Plate System

For more information, please visit us at Infonomics.com