Medtronic Sofamor Danek CD HORIZON® SOLERA® Spinal System. Catalog #54850016545

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Feb 4, 20182 min read

Updated: May 2, 2024

Vendor/Manufacturer: Medtronic Sofamor Danek

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

Vendor/Manufacturer Catalog #: 54850016545

Global Unique Device (GUD) Primary Device Identifier Number: 00643169491564

Global Unique Device (GUD) Device Description:

MAS 54850016545 4.75 EXT TAB CANN 6.5 X 45

Category 1: Spine

Category 2: Lumbar Pedicle Screw Systems

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:

Pedicle Screw Spinal System

FDA Classification Product Code: HBE, KWP, KWQ, MNH, MNI, NKB, OLO, OSH

FDA Classification Product Code Device Name:

HBE: Drills, Burrs, Trephines & Accessories (Simple, Powered)

KWP: Appliance, Fixation, Spinal Interlaminal

KWQ: Appliance, fixation, spinal intervertebral body

MNH: Orthosis, spondylolisthesis spinal fixation

MNI: Orthosis, Spinal Pedicle Fixation