Device Dossier

Modus Nav - Stereotactic surgery system, neurological

Device Dossier for Modus Nav - Stereotactic surgery system, neurological (Stereotactic surgery system, neurological, Class IIb, sponsor Inovanz). ARTG…

Intended purpose

Modus Nav is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the “Accuracy Characterization” section of the User Manual to assess if the accuracy of the system is suitable for their needs. The system hardware and software should be used only by qualified medical professionals who are trained in performing surgery and are familiar with image-guided surgical systems.

TGA Public Summary