Device Dossier
Cervical total disc replacement prosthesis
Device Dossier for Cervical total disc replacement prosthesis (Cervical total disc replacement prosthesis, Class IIb, sponsor Globus Medical). ARTG…
- GMDN category: Cervical total disc replacement prosthesis
Intended purpose
The SECURE-C Cervical Artificial Disc is indicated for treatment of symptomatic cervical disc disease (SCDD) from C3-C7. SCDD is defined as neck or arm pain, or functional or neurological deficit confirmed by patient history and radiographic studies demonstrating primary or recurrent disc herniation, radiculopathy or myelopathy, spondylosis, spinal stenosis and/or loss of disc height.