Medtronic Sofamor Danek VERTEX. Cervical Pedicle Screw System SET SCREW. Two-Level. Catalog #6950315

Vendor/Manufacturer: Medtronic Sofamor Danek Product/Product Line: VERTEX Set Screw Vendor/Manufacturer Catalog #: 6950315 Global Unique Device (GUD) Primary Device Identifier Number: 00885074451237 Global Unique Device (GUD) Device Description: SET SCREW 6950315 M6 SET SCREW 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: Set 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, K042498 SUBSTANTIALLY EQUIVALENT to the following products: 1. VERTEX® Reconstruction System 2. INFINITY™ OCT System