ASTRA-OCT Spine System - Bone-screw internal spinal fixation system, non-sterile

Intended purpose

This system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3): § Traumatic spinal fractures and/or Traumatic dislocations; § Instability or deformity; § Failed previous fusions (e.g. pseudoarthrosis); § Tumors involving the cervical/thoracic spine; and § Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. This system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.