(137 days)
The RELIEVE™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE™ Laminoplasty Fixation System is used to hold the bone allograft material in place in order to prevent the allograft from expulsion, or impinging the spinal cord.
The RELIEVE™ Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. RELIEVE™ implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Plates may be filled with bone graft material. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy. RELIEVE™ plates are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560. Screws are made from titanium alloy, as specified in F136 and F1295.
The provided text is a 510(k) summary for the RELIEVE™ Laminoplasty Fixation System. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria, device performance, results of any studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot provide the requested table and study details. The document is a regulatory approval notice based on substantial equivalence, not a performance study report.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.