Vendor/Manufacturer: Zimmer Biomet
Product/Product Line: C-TEK ® MaxAn® Plate
Vendor/Manufacturer Catalog #: 14-522230
Global Unique Device (GUD) Primary Device Identifier Number: 00880304961166
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: Two 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:
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