The FDA granted 510(k) clearance to Zavation’s Normandy vertebral body replacement system.

The device is placed in the vertebral body space to provide structural stability in skeletally mature patients. It is made up of spacers that come in various sizes and types to accommodate the patient’s anatomy.

The device is indicated for use in the cervical and thoracolumbar spine for replacement of vertebral body due to tumor, trauma or osteomyelitis, or for reconstruction following the removal of vertebral body and discs.