DevicePMAs@therightstef:P090029_S000 JSONTXT 11 Projects

Approval for the prestige lp cervical disc. this device is indicated in skeletally mature patients for reconstruction of the disc at one level from c3-c7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level abnormality localized to the level of the disc space and at least one of the following conditions confirmed by imaging (ct, mri, x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. the prestige lp cervical disc is implanted using an anterior approach. patients should have failed at least 6 weeks of non-operative treatment or have had the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management prior to implantation of the prestige lp cervical disc.