Device Dossier

Cervical total disc replacement prosthesis

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

Intended purpose

Intended to replace the cervical disc in patients with symptomatic degenerative disc disease at cervical levels C3-7. A symptomatic degenerative disc is defined as neck or arm (radicular) pain and/or a functional/neurological deficit confirmed by radiographic studies.Intended for use only if conservative care fails to reduce symptoms.

TGA Public Summary