Precision Spine AccuFit® Lateral Plate System. Catalog #58-LP-0030

Vendor/Manufacturer: Precision Spine

Product/Product Line: AccuFit® Lateral Plate System

Vendor/Manufacturer Catalog #: 58-LP-0030

Global Unique Device (GUD) Primary Device Identifier Number: 00840019904452

Global Unique Device (GUD) Device Description:

30mm 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).

Category 1: Spine

Category 2: Thoracolumbar Plate & Screw Systems

Category 3: Plate

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: K162211

The Precision Spine AccuFit® Lateral Plate System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Synthes Thoracolumbar Spine Locking Plate (TSLP) System

2. Spinal USA Anterior Lumbar Plate System

3. Eminent Spine Black/Red Diamond Rattlesnake Lumbar Plating System

For more information, please visit us at Infonomics.com