Device Dossier

Spinal cage

Device Dossier for Spinal cage (Spinal cage, Class IIb, sponsor Medacta). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

Fixation devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The interior of the spacer component of the device can be packed with autograft or autologous bone graft. These patients should be skeletally mature and have had at least six months of non-operative treatment.

TGA Public Summary