CoreLink ANODYNE® Anterior Cervical Plate System. Catalog #20004-100

Vendor/Manufacturer: CoreLink

Product/Product Line: ANODYNE® Anterior Cervical Plate System

Vendor/Manufacturer Catalog #: 20004-100

Global Unique Device (GUD) Primary Device Identifier Number: M72520004100

Global Unique Device (GUD) Device Description:

ANODYNE CERVICAL PLATE - 4 LEVEL, 100MM

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Bone-screw internal spinal fixation system, non-sterile

Global Medical Device Nomenclature (GMDN) Definition:

An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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: K121514

The CoreLink ANODYNE® Anterior Cervical Plate System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Medtronic Atlantis

2. Medtronic Orion