Device Dossier
Lumbar total disc replacement prosthesis
Device Dossier for Lumbar total disc replacement prosthesis (Lumbar total disc replacement prosthesis, Class IIb, sponsor Evolution Surgical). ARTG…
- GMDN category: Lumbar total disc replacement prosthesis
Intended purpose
Intended to replace the lumbar disc in patients with symptomatic Degeneratice Disc Disease (DDD) at lumbar levels L3-S1. A symptomatic degenerative disc is defined as back pain associated with structural changes confirmed by patient history and radiographic studies. Intended for use only if conservative care fails to reduce symptoms.