Device Dossier

Spinal cage

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

Intended purpose

Intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. To be used with bone graft material packaged within the implant to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. For Degenerative Disc Disease (DDD) at one or multiple levels from L2 to S1. These DDD patients may also have grade 1 and potentially grade 2 or 3 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

TGA Public Summary