Device Dossier

Spinal fixation plate, non-biodegradable

Device Dossier for Spinal fixation plate, non-biodegradable (Spinal fixation plate, non-biodegradable, Class IIb, sponsor Nuvasive (Aust/NZ)). ARTG…

Intended purpose

The NuVasive Anterior Cervical Plate systems are intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilisation as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis, or failed previous fusion.

TGA Public Summary