Device Dossier

Bone-screw internal spinal fixation system, non-sterile

Device Dossier for Bone-screw internal spinal fixation system, non-sterile (Bone-screw internal spinal fixation system, non-sterile, Class IIb, sponsor…

Intended purpose

Intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput –T3). Indicated for: Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Spinal Stenosis, Fracture/Dislocation, Atlantoaxial fracture with instability, Occipitocervical dislocation, Revision of previous spine surgery, Tumors.

TGA Public Summary