Device Dossier

Fixation system, internal,fracture, non-biodegradable

Device Dossier for Fixation system, internal,fracture, non-biodegradable (Fixation system, internal,fracture, non-biodegradable, Class IIb, sponsor…

Intended purpose

For use in the treatment of thoracolumbar spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

TGA Public Summary