(27 days)
The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The DePuy AcroMed VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the DePuy AcroMed VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, and Profile).
Additional size components in various sizes and footprints. The DePuy AcroMed VBR System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification.
The provided text describes a medical device, the DePuy AcroMed VBR System, and its indications for use in the context of a 510(k) premarket notification. It does NOT contain information about acceptance criteria, device performance metrics, or any studies demonstrating that the device meets specific performance criteria.
The document states: "Performance data were submitted to characterize the additional components of the DePuy AcroMed VBR System." However, the actual performance data, acceptance criteria, or details of the study itself are not included in the provided text.
Therefore, according to the input, I cannot furnish the requested information.
§ 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.