Device Dossier

Spinal fixation plate, non-biodegradable

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

Intended purpose

A Cervical Plating system designed to be used from C2-T1 for the following indications: for degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

TGA Public Summary