Zimmer Biomet Virage® OCT Spinal Fixation System. Catalog #07.01710.001

Vendor/Manufacturer: Zimmer Biomet

Product/Product Line: Virage® OCT Spinal Fixation System

Vendor/Manufacturer Catalog #: 07.01710.001

Global Unique Device (GUD) Primary Device Identifier Number:

00889024328488

Global Unique Device (GUD) Device Description: 

Rod

Category 1: Spine

Category 2: Posterior Cervical Systems

Category 3: Rod

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: 888.3075

FDA Regulation Description Classification Name: 

Posterior cervical screw system

FDA Classification Product Code(s): KWP

FDA Classification Product Code Device Name(s): 

KWP: Appliance, Fixation, Spinal Interlaminal

FDA Premarket Submissions: K153631

The Zimmer Biomet Virage® OCT Spinal Fixation System is

SUBSTANTIALLY EQUIVALENT to the following product(s): 

1. Nuvasive OCT System

2. Zimmer MINIT Posterior Cervical and Upper Thoracic Fixation System

3. Zimmer Biomet VIRAGE® OCT Spinal Fixation System - previous versions

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