Device Dossier

Surgical procedure kit, orthopaedic, single-use, non-medicated

Device Dossier for Surgical procedure kit, orthopaedic, single-use, non-medicated (Surgical procedure kit, orthopaedic, single-use, non-medicated, Class…

Intended purpose

The single-use surgical instruments are necessary to perform surgical procedures including osteosynthesis and kyphoplasty. Guidewires and drills are used to prepare bones and facilitate the implantation of orthopaedic plate systems, intramedullary nailing systems, spinal fixation systems and kyphoplasty procedures.

TGA Public Summary