Precision Spine AccuFit® Lateral Plate System. Catalog #58-SC-1000

Vendor/Manufacturer: Precision Spine

Product/Product Line: AccuFit® Lateral Plate System

Vendor/Manufacturer Catalog #: 58-SC-1000

Global Unique Device (GUD) Primary Device Identifier Number: 00840019919876

Global Unique Device (GUD) Device Description:

AccuFit® LP Case

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Orthopaedic surgical procedure kit, non-medicated, reusable

Global Medical Device Nomenclature (GMDN) Definition:

A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

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