(29 days)
The ORIA ZENITH is intended for anterior screw fixation of the cervical spine and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include failed previous fusion, pseudarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis or degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
WARNING: The ORIA ZENITH is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The ORIA ZENITH is a cervical plate system consisting of plates and screws manufactured from titanium alloy (ASTM F 136). Plates are available in a variety of lengths. Fixed and variable screws are available in a variety of lengths and diameters of 4.0 and 4.5mm. A self-tapping version of each screw is also available.
The provided text is a 510(k) summary for the ORIA ZENITH cervical plate system. It describes the device, its intended use, materials, and substantial equivalence to a previously cleared device. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, or comparative effectiveness studies.
The 510(k) summary focuses solely on demonstrating substantial equivalence to a predicate device based on design, materials, manufacturing, and intended use. There is no performance data or study results included.
Therefore, I cannot populate the requested table and answer the specific questions about device performance and studies based on the provided text.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.