Device Dossier

Cervical total disc replacement prosthesis

Device Dossier for Cervical total disc replacement prosthesis (Cervical total disc replacement prosthesis, Class IIb, sponsor Emergo). ARTG record,…

Intended purpose

The device is a disc prosthesis for use in the cervical spine (C3 – C7). Unlike a cage, in addition to restoring disc height this implant maintains physiological movement. It is used following an anterior approach and cervical discectomy in the following indications: Discopathy, Disc herniation, and Stenosis of the foramen and spinal canal.

TGA Public Summary