(111 days)
The Origin Anterior Cervical Plate System is interior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvature (i.e., scoliosis, kyphosis), tumor, pseudoarthrosis, and failed previous fusion.
Origin Anterior Cervical Plate System is an anterior cervical fixation system comprised of a titanium plate, and bone screws, both in multiple sizes. The Plate features multiple holes designed to receive and secure bone screws. The Plate System is provided non-sterile and is intended for single use.
This document is a 510(k) summary for the Origin™ Anterior Cervical Plate System, a medical device for spinal fixation. It does not contain information about an AI/ML device or its performance characteristics. Therefore, I cannot provide the requested information about acceptance criteria, study details, ground truth, or multi-reader multi-case studies, as described in the prompt.
The document describes a traditional medical device (an anterior cervical plate system) and its submission for FDA clearance based on substantial equivalence to predicate devices, supported by performance data from mechanical testing.
§ 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.