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 VIP™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2- C7 for the following indications: 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 (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis and spinal stenosis.

TGA Public Summary