Device Dossier

Robotic surgical system

Device Dossier for Robotic surgical system (Robotic surgical system, Class IIa, sponsor Amplitude). ARTG record, intended purpose, GMDN category —…

Intended purpose

The andy - Surgical Robot is intended to be used in combination with the AMPLIVISION navigation station and software, and robotic surgical instruments, to implant medical devices manufactured and/or distributed by Amplitude. It is a motorised orthopaedic surgical arm designed to assist the surgeon to perform precise bone cuts during arthroplasty. The device is reusable and non-invasive.