Zavation receives FDA 510(k) clearance for cervical, thoracolumbar expandable corpectomy cage
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Zavation announced it received FDA 510(k) clearance to market the Normandy VBR System, a cervical and thoracolumbar expandable corpectomy cage.
According to a company press release, the Normandy VBR System is vertebral body replacement device with adjustable height. It is implanted to provide structural stability in skeletally mature patients after corpectomy or vertebrectomy. The device is intended for the cervical spine and thoracolumbar spine in skeletally mature patients for a partial or total replacement of a diseased, collapsed, damaged or unstable vertebral body. It is also intended for reconstruction after corpectomy to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The Normandy VBR System is to be used with either autograft or allogenic bone graft made of cancellous and/or corticocancellous bone graft.
Reference:
zavation.com