(103 days)
The Eminent Spine Fang Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
The Eminent Spine Fang Plate System consists of a plate and screw. The plate, which is available in two sizes (24nm and 27mm), is designed with an 8° bend to conform to the anatomy of the anterior spine to prevent migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. Additionally, the plate features two "fangs" that prevent rotation, and a screw slot for final fixation. The 5.5mm screws are available in 20mm and 25mm lengths.
The provided text describes the "Eminent Spine Fang Plate System" and states that "Mechanical test results demonstrate that the Eminent Spine Fang Plate System is substantially equivalent to the predicate device." However, the document does not provide specific acceptance criteria or the detailed results of the study proving the device meets those criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or training set details as this information is not present in the provided text.
The available information only states:
- Study performed: Mechanical testing.
- Outcome: The Eminent Spine Fang Plate System was determined to be substantially equivalent to the MacroPore OS Spinal System (K010911) based on these mechanical test results.
§ 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.