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

A bone screw spinal implant assembly that consists of a combination of anchors (e.g. bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g. plates, rods, plate/rod combinations), and/or transverse connectors intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

TGA Public Summary