Device Dossier

Spinal fixation plate, non-biodegradable

Device Dossier for Spinal fixation plate, non-biodegradable (Spinal fixation plate, non-biodegradable, Class IIb, sponsor Emergo). ARTG record, intended…

Intended purpose

Intended for anterior intervertebral screw fixation of the cervical spine from C2 – T1. Indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Decompression of the spinal cord following total or partial cervical vertebrectomy, Trauma (including fractures), Tumors, Deformities or curvatures (including kyphosis, lordosis or scoliosis), Pseudoarthrosis, Failed previous fusions, Spondylolisthesis, Spinal stenosis.

TGA Public Summary