Device Dossier

Orthopaedic bone screw, non-biodegradable

Device Dossier for Orthopaedic bone screw, non-biodegradable (Orthopaedic bone screw, non-bioabsorbable, sterile, Class IIa, sponsor Relax Retractors).…

Intended purpose

Non implantable bone screw sold as sterile pair or single item for transient anchorage of cervical or lumbar retraction systems (typically made of Radel) to the patient during spinal surgical procedures. Examples include distraction screw (Casper style) to temporarily fix the CAX retractor frame to a vertebral body or "Curvy" style lumbar screw for temporary fixation of a retraction device onto bone to create a surgical view.

TGA Public Summary