Medtronic Sofamor Danek VERTEX. Cervical Pedicle Screw System. SCREW. Two-Level. Catalog #6958714

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: VERTEX Screw

Vendor/Manufacturer Catalog #: 6958714

Global Unique Device (GUD) Primary Device Identifier Number: 00613994355041

Global Unique Device (GUD) Device Description:

SCREW 6958714 3.5 X 14MM MAS

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: Screw

Category 4: Two Level

Quantity of "Each"es needed in each System/Set: 6

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: K123656, K180851, K042789

SUBSTANTIALLY EQUIVALENT to the following products:

1. VERTEX® Reconstruction System

2. INFINITY™ OCT System