Device Dossier
Spinal cage
Device Dossier for Spinal cage (Spinal cage, Class IIb, sponsor Life Healthcare). ARTG record, intended purpose, GMDN category — compiled by arcimedes.
- GMDN category: Spinal cage
Intended purpose
The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.