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

The CITADEL™ Anterior Lumbar Plate System is intended for use by an anterior or anterolateral approach in the treatment of lumbar and lumbosacral (L1-S1) 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), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

TGA Public Summary