K2M CAYMAN® Plate System. Catalog #1408-40F22

Vendor/Manufacturer: K2M

Product/Product Line: CAYMAN® Plate System

Vendor/Manufacturer Catalog #: 1408-40F22

Global Unique Device (GUD) Primary Device Identifier Number: 10888857020047

Global Unique Device (GUD) Device Description:

Buttress 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: K080302

The K2M CAYMAN® Buttress Plate System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Seaspine Anterior Lumbar Buttress System

2. BowTi Anterior Staple System

3. Synthes Titanium Locking Plate System

4. Altiva Buttress Plating System

5. Medtronic Sofiamor Danek Bone Graft Washer

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