Medtronic Sofamor Danek CD HORIZON® Spinal System. Catalog #55840026545T

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: CD HORIZON® Spinal System

Vendor/Manufacturer Catalog #: 55840026545T

Global Unique Device (GUD) Primary Device Identifier Number:

00643169678835

Global Unique Device (GUD) Device Description:

MAS 55840026545T 5.5/6.0 FENSTRTD 6.5X45

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: 888.3070

FDA Regulation Description Classification Name:

Thoracolumbosacral pedicle screw system

FDA Classification Product Code(s): MNI

FDA Classification Product Code Device Name(s):

MNI: Orthosis, Spinal Pedicle Fixation

FDA Premarket Submissions: K152604 , K193011

The Medtronic Sofamor Danek CD HORIZON® Spinal System is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Medtronic CD HORIZON® Spinal System - previous versions

2. Medtronic CD HORIZON® Fenestrated Screw Set - previous versions

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