Device Dossier

Ultrasonic Osteotomy Surgical System - Ultrasonic surgical system generator

Device Dossier for Ultrasonic Osteotomy Surgical System - Ultrasonic surgical system generator (Ultrasonic surgical system generator, Class IIb, sponsor…

Intended purpose

The console is part of the Ultrasonic Osteotomy Surgical System indicated for surgeon use to cut and reshape bone tissues as used in spine surgery, neurosurgery (bone only), orthopedics surgery and bone surgery. The system console is composed of an integrated peristaltic pump, a display, together with receptacles for the footswitch and handpiece. The console activates and controls the ultrasound vibration, controls irrigation flow and displays system condition.

TGA Public Summary