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Medtronic Sofamor Danek CD HORIZON® SOLERA® Spinal System. Catalog #1553201040

Updated: May 1



Vendor/Manufacturer: Medtronic Sofamor Danek

Vendor/Manufacturer Catalog #: 1553201040

Global Unique Device (GUD) Primary Device Identifier Number:

00643169015968

Global Unique Device (GUD) Device Description:

ROD 1553201040 5.5 TI CP4 NS CURV 40MM


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: Rod


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: KWP, KWQ, MNH, MNI, NKB, OSH

FDA Classification Product Code Device Name:

KWP: Appliance, Fixation, Spinal Interlaminal

KWQ: Appliance, Fixation, Spinal Intervertebral Body

MNH: Orthosis, Spondylolisthesis Spinal Fixation

MNI: Orthosis, Spinal Pedicle Fixation

NKB: Thoracolumbosacral Pedicle Screw System

OSH: Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis


FDA Premarket Submission: K162379 , K113174 , K202771


The Medtronic Sofamor Danek CD HORIZON® SOLERA® Spinal System is

SUBSTANTIALLY EQUIVALENT to the following products:





For more information, please visit us at Infonomics.com

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