Device Dossier

Custom-made orthopaedic surgical guide, non-sterile

Device Dossier for Custom-made orthopaedic surgical guide, non-sterile (Custom-made orthopaedic surgical guide, non-sterile, Class IIa, sponsor Medacta).…

Intended purpose

Device intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

TGA Public Summary