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…
- GMDN category: Cervical total disc replacement prosthesis
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.