NuVasive® ACP System. Catalog #18008115

Vendor/Manufacturer: Nuvasive

Product/Product Line: ACP System

Vendor/Manufacturer Catalog #: 18008115

Global Unique Device (GUD) Primary Device Identifier Number: 00195377009395

Global Unique Device (GUD) Device Description:

ACP Screw, 3.5x15mm Self-Drill Variable

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: Cervical Plate & Screw Systems

Category 3: Screw

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: K201078

The NuVasive® ACP System is

SUBSTANTIALLY EQUIVALENT to the following product:

1. NuVasive Helix Mini ACP System

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