Device Dossier
Stereotactic surgery system, orthopaedic
Device Dossier for Stereotactic surgery system, orthopaedic (Stereotactic surgery system, orthopaedic, Class IIa, sponsor Emergo). ARTG record, intended…
- GMDN category: Stereotactic surgery system, orthopaedic
Intended purpose
The software medical device is intended for use during stereotaxic surgery. It is dedicated to intraoperative use in orthopedic surgery. The device is installed on an execution platform and is intended to navigate surgical instruments. Indeed, the software device locates specific instruments in a 3D reference frame that are equipped with markers to provide anatomical landmarks and axes. The device aids the surgeon in locating anatomical structures and navigating the instruments.