Device Dossier

Polymeric spinal fusion cage, non-sterile

Device Dossier for Polymeric spinal fusion cage, non-sterile (Polymeric spinal interbody fusion cage, Class IIb, sponsor Wiselink Group). ARTG record,…

Intended purpose

The device is a fusion device intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The Cervical cage is intended for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. The Thoracic and Lumbar cage is intended for use with autogenous bone grafts in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1.

TGA Public Summary