Stryker AVIATOR®. Cervical Plate & Screw System. PLATE. Two-Level. Cat #48811212

Vendor/Manufacturer: Stryker

Product/Product Line: AVIATOR Plate

Vendor/Manufacturer Catalog #: 48811212

Global Unique Device (GUD) Primary Device Identifier Number: 07613252152101

Global Unique Device (GUD) Device Description:

ONE-LEVEL ANTERIOR PLATE

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Spinal fixation plate, non-bioabsorbable

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:

1. Synthes Spine Cervical Spine Locking Plate System

2. Stryker Spine Reflex® Hybrid ACP System

3. Stryker Spine Aviator® Anterior Cervical Plating (ACP) System