Medtronic Sofamor Danek CLYDESDALE PTC™ Spinal System. Catalog #4920860

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: CLYDESDALE PTC™ Spinal System

Vendor/Manufacturer Catalog #: 4920860

Global Unique Device (GUD) Primary Device Identifier Number:

00643169190825

Global Unique Device (GUD) Device Description:

CAGE 4920860 CDALE PTC 22MM 0 DEG 8 X 60

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Polymeric spinal fusion cage, sterile

Global Medical Device Nomenclature (GMDN) Definition:

A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3080

FDA Regulation Description Classification Name:

Intervertebral body fusion device

FDA Classification Product Code: MAX

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Submissions: K133205

The Medtronic Sofamor Danek CLYDESDALE PTC™ Spinal System is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. CLYDESDALE Spinal System

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