BAGUERA®C Cervical Disc Prosthesis

Approval order statement

The BAGUERA® C Cervical Disc Prosthesis is indicated for use in skeletally mature patients for reconstruction of the disc at one or two contiguous levels from C3-C7 following single-level or two-contiguous-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level or two-contiguous-level abnormality localized to the level of the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (e.g., X-rays, computed tomography (CT), magnetic resonance imaging (MRI)): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. Patients receiving the BAGUERA® C Cervical Disc Prosthesis should have failed at least six weeks of non-operative treatment or have the presence of progressive symptoms (e.g., numbness or tingling) prior to implantation. The BAGUERA® C Cervical Disc Prosthesis is implanted via an open anterior approach.