Zimmer Biomet VIRAGE. Cervical Pedicle Screw System. ROD. One-Level. Catalog #07.01709.003

Vendor/Manufacturer: Zimmer Biomet

Product/Product Line: VIRAGE Rod

Vendor/Manufacturer Catalog #: 07.01709.003

Global Unique Device (GUD) Primary Device Identifier Number: 00889024328440

Global Unique Device (GUD) Device Description:

Spinal Rod

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Bone-screw internal spinal fixation system, non-sterile

Category 1: Spine

Category 2: Cervical Pedicle Screw Systems

Category 3: Rod

Category 4: One Level

Quantity of "Each"es needed in each System/Set: 2

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3050

FDA Regulation Description Classification Name:

Spinal interlaminal fixation orthosis

FDA Classification Product Code: KWP

FDA Classification Product Code Device Name:

Appliance, Fixation, Spinal Interlaminal

FDA Premarket Submissions: K153631

SUBSTANTIALLY EQUIVALENT to the following products:

1. Nuvasive OCT System

2. Zimmer Minit Posterior Cervical and Upper Thoracic Fixation System