Device Dossier
Optical surgical navigation device tracking system
Device Dossier for Optical surgical navigation device tracking system (Optical surgical navigation device tracking system, Class IIa, sponsor Compliance…
- GMDN category: Optical surgical navigation device tracking system
Intended purpose
The device provides real?time visual representation of the position and alignment of surgical instruments and implants relative to the patient's anatomy, assisting the surgeon in achieving the desired positioning and alignment during the surgical procedure. Device performance depends on the surgeon's instructions and clinical judgment. It is intended for use exclusively by qualified orthopedic surgeons in hospital or clinical settings, in accordance with the user manual and applicable regulations.