Vendor/Manufacturer: Nuvasive
Product/Product Line: ACP System
Vendor/Manufacturer Catalog #: 18008513
Global Unique Device (GUD) Primary Device Identifier Number: 00887517065391
Global Unique Device (GUD) Device Description:
ACP Screw, 4.0x13mm Self-Tap 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:
For more information, please visit us at Infonomics.com
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