Cervical Spinal Disc Implant Plate Fixation - Vietnam Registration 2402016ĐKLH/BYT-HTTB

Purpose: The DIVERGENCE™ Cervical Disc Spacer with Screw Fixation is a device intended for the surgical treatment of the cervical spine in adult patients with a clinical diagnosis of cervical disc disease at a single level from C2-C3 to C7-T1. The device is intended to be used as a replacement for a single level in the anterior cervical spine from C2-T1. Indications: The DIVERGENCE™ Cervical Disc Spacer with Screw Fixation is a device intended for the surgical treatment of the cervical spine in adult patients with a clinical diagnosis of cervical disc disease at a single level from C2-C3 to C7-T1. Cervical disc disease is defined as a primary neurological disorder that is refractory and/or a spinal cord disorder with disc herniation and/or formation of osteophytes at the endplate of the lower cervical vertebrae creating a symptomatic and/or compressive effect on the spinal cord, as confirmed by radiographic studies. The DIVERGENCE™ Cervical Disc Spacer with Screw Fixation must be used in conjunction with internal screw fixation. The DIVERGENCE™ Cervical Disc Spacer with Screw Fixation must be used in conjunction with autogenous bone grafting and the surgical procedure must be performed through an anterior approach. The device is intended for use in patients who have been treated non-surgically for a period of six weeks. Patients who have undergone anterior cervical discectomy and fusion at the relevant level may be candidates for the device.