Device Dossier

Polymeric spinal fusion cage, sterile

Device Dossier for Polymeric spinal fusion cage, sterile (Polymeric spinal fusion cage, sterile, Class IIb, sponsor Emergo). ARTG record, intended…

Intended purpose

The ulrich PEEK cages support the intervertebral space in the lumbar, lumbosacral and cervical spine in humans with the purpose of supporting bone fusion of the vertebral bodies and support for spondylodesis. The implants are inserted individually or in pairs between two vertebral bodies. The implants can also serve as a means of restoring the spinal profile. Additional stabilizing instrumentation is necessary, for example, with a pedicle screw-rod-system. Indications for fusion procedures are for example: Degenerative disk disease, Post-diskectomy syndrome, Revision following disk surgery, Degenerative instability, Lytic spondylolisthesis, Congenital malposition such as scoliosis, Spinal stenosis with clinical instability, Pseudarthrosis, Spondylolisthesis and retrolisthesis grade 1, Degenerative scoliosis, Pseudarthrosis.

TGA Public Summary