Medtronic Sofamor Danek CD HORIZON® SOLERA® Spinal System. Catalog #55840006545

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: CD HORIZON® SOLERA® Spinal System

Vendor/Manufacturer Catalog #: 55840006545

Global Unique Device (GUD) Primary Device Identifier Number: 00613994971753

Global Unique Device (GUD) Device Description:

SCREW 55840006545 5.5/6 MAS 6.5X45 CC

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.

Category 1: Spine

Category 2: Lumbar Pedicle Screw Systems

Category 3: Screw

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: NKB

FDA Classification Product Code Device Name:

Thoracolumbosacral Pedicle Screw System

FDA Premarket Submission: K113174