Device Dossier

Spinal fixation plate, non-biodegradable

Device Dossier for Spinal fixation plate, non-biodegradable (Spinal fixation plate, non-biodegradable, Class IIb, sponsor Evolution Surgical). ARTG…

Intended purpose

The Anterior Cervical Plate System is intended for anterior plate and screw fixation of the cervical spine as an adjunct to fusion. The plates and screws have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease, spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumour, pseudarthrosis or failed previous fusion.

TGA Public Summary