(59 days)
The ZEVO™ Anterior Cervical Plate System is interior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) turnors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions
The ZEVO™ Anterior Cervical Plate System consists of temporary implants (plates and bone screws) intended for anterior screw fixation of the cervical spine during the development of a cervical spinal fusion. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The device is intended for the anterior screw fixation from C2- T1 in the cervical spine.
The ZEVO™ Anterior Cervical Plate System implants are available in a broad range of size offerings, and are supplied in both sterile and non-sterile form.
The implant components are made from titanium alloy, with plates having subcomponents manufacturing from nitinol (NiTi).
The purpose of this submission is to establish MR Conditional labeling for this implant system.
This submission (K231090) describes the ZEVO™ Anterior Cervical Plate System. However, this document does not contain information regarding an AI/ML device.
The purpose of this submission is to establish MR Conditional labeling for this implant system. The document focuses on demonstrating the magnetic resonance (MR) safety of the ZEVO™ Anterior Cervical Plate System through non-clinical testing.
Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or adjudication methods related to an AI/ML device, as this document does not pertain to such a device.
§ 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.