Zeta Surgical, Inc. - FDA 510(k) Cleared Devices

Zeta Surgical, Inc. develops AI-powered neuronavigation systems for brain surgery and neuromodulation. The company operates with a manufacturing facility in Boston, US. Their platform delivers real-time, frameless image-guided navigation with submillimeter accuracy across operating rooms, emergency settings, and ambulatory centers.

Zeta Surgical has received 4 FDA 510(k) clearances from 4 total submissions since 2024. The company specializes exclusively in Neurology devices, with its most recent clearance in 2026. All submissions have resulted in clearances, demonstrating a strong regulatory track record.

The Zeta Navigation System and related navigated instruments enable precise spatial positioning for cranial procedures including ventriculostomy, brain biopsy, tumor resection, and transcranial magnetic stimulation therapy. The platform eliminates the need for skull fixation and general anesthesia in many cases, improving surgical efficiency and patient safety outcomes.

Explore the company's cleared device names, product codes, and clearance dates in the full regulatory database.