K2M CAYMAN® Thoracolumbar Plate System. Catalog #1208-41F97

Vendor/Manufacturer: K2M

Product/Product Line: CAYMAN® Thoracolumbar Plate System

Vendor/Manufacturer Catalog #: 1208-41F97

Global Unique Device (GUD) Primary Device Identifier Number: 10888857019416

Global Unique Device (GUD) Device Description:

Thoracolumbar Plate

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: KWQ

FDA Classification Product Code Device Name:

Appliance, Fixation, Spinal Intervertebral Body

FDA Premarket Submission: K081380

The K2M CAYMAN® Thoracolumbar Plate System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Blackstone Medical Unity Anterior Lumbar Plate Fixation System

2. Synthes Thoracolumbar Spine Locking Plate

3. Medtronic Sofamor Danek Pyramid Anterior Plate Fixation System

4. Medtronic Sofamor Danek Z-Plate

For more information, please visit us at Infonomics.com