Device Dossier

Spinal cage

Device Dossier for Spinal cage (Spinal cage, Class IIb, sponsor Globus Medical). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

The COALITION® Spacers (COALITION®, COALITION AGX® Spacer and Plate assembly, COALITION® TPS, COALITION MIS®) are stand-alone interbody fusion device intended for use in cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The spacer is to be filled with bone graft material.

TGA Public Summary