Nuvasive DECADE Lateral Plate System. Catalog #7145545

Vendor/Manufacturer: Nuvasive

Product/Product Line: DECADE Lateral Plate System

Vendor/Manufacturer Catalog #: 7145545

Global Unique Device (GUD) Primary Device Identifier Number:

00887517317469

Global Unique Device (GUD) Device Description:

XLIF Decade Plate Bolt, 5.5x45mm Large

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Spinal bone screw, non-bioabsorbable

Global Medical Device Nomenclature (GMDN) Definition:

A small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it 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 available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Category 1: Spine

Category 2: Thoracolumbar Plate and Screw System

Category 3: Bolt

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: K130868

The Nuvasive DECADE Lateral Plate System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. NuVasive® Sage Lateral Plate System

2. NuVasive® Halo II Anterior Lumbar Plate System

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