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

An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion. It typically 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. Non-sterile disposable devices associated with implantation may be included.

TGA Public Summary