Zimmer Biomet C-TEK ® MaxAn®. Cervical Plate & Screw System. PLATE. One-Level. Cat #14-522109

Vendor/Manufacturer: Zimmer Biomet

Product/Product Line: C-TEK ® MaxAn® Plate

Vendor/Manufacturer Catalog #: 14-522109

Global Unique Device (GUD) Primary Device Identifier Number: 00880304961395

Global Unique Device (GUD) Device Description:

C-TEK® MAXAN® ANTERIOR CERVICAL PLATE SYSTEM

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Bone-screw internal spinal fixation system, non-sterile

Category 1: Spine

Category 2: Cervical Plate & Screw Systems

Category 3: Plate

Category 4: One Level

Quantity of "Each"es needed in each System/Set: 1

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3060

FDA Regulation Description Classification Name:

Spinal intervertebral body fixation orthosis

FDA Classification Product Code: KWQ

FDA Classification Product Code Device Name:

Appliance, Fixation, Spinal Intervertebral Body

SUBSTANTIALLY EQUIVALENT to the following products:

1. C-TEK ® MaxAn® Anterior Cervical Plate System