Medical Device Manufacturer · US , Boston , MA

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

5 submissions · 5 cleared · Since 2024

Recent clearances: Zeta Navigation System, Zeta Navigation System (ZNS131-US), Zeta Cranial Navigation System (ZNS131-US)

Official Website

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Zeta Surgical, Inc. Neurology ✕

5 devices

1-5 of 5

Cleared Jul 09, 2026

Zeta TMS Navigation System

Neurology · 66d

Cleared May 01, 2026

Zeta Navigation System

Neurology · 162d

Cleared Oct 10, 2025

Zeta Navigation System (ZNS131-US)

Neurology · 109d

Cleared Oct 04, 2024

Zeta Cranial Navigation System (ZNS131-US)

Neurology · 57d

Cleared Jan 10, 2024

Zeta Cranial Navigation System (ZNS131-US)

Neurology · 30d