FDA 510(k) Clearance: Zeta Surgical Zeta Navigation System for Neurosurgical Navigation
[in effect]United States · permit · permit
Jurisdiction
United States
Classification
permit
Status
in effect
Effective Date
May 1, 2026
Primary Sources
1 audited
Statutory Scope & Summary
FDA granted 510(k) clearance for ZETA Surgical Zeta Navigation System alongside its navigated instruments (Zeta Stylet and Zeta Bolt) for neurosurgical navigation.
Covered Sectors & Application Domains
Regulatory Analysis & Inquiries
6 entriesWhat does FDA 510(k) Clearance: Zeta Surgical Zeta Navigation System for Neurosurgical Navigation cover?
FDA granted 510(k) clearance for ZETA Surgical Zeta Navigation System alongside its navigated instruments (Zeta Stylet and Zeta Bolt) for neurosurgical navigation.
Where does FDA 510(k) Clearance: Zeta Surgical Zeta Navigation System for Neurosurgical Navigation apply?
FDA 510(k) Clearance: Zeta Surgical Zeta Navigation System for Neurosurgical Navigation is recorded as a permitting requirement applying in United States on the DEPLOY registry.
When did FDA 510(k) Clearance: Zeta Surgical Zeta Navigation System for Neurosurgical Navigation take effect?
FDA 510(k) Clearance: Zeta Surgical Zeta Navigation System for Neurosurgical Navigation is recorded as effective May 1, 2026 on the DEPLOY registry.
Is FDA 510(k) Clearance: Zeta Surgical Zeta Navigation System for Neurosurgical Navigation still in effect?
FDA 510(k) Clearance: Zeta Surgical Zeta Navigation System for Neurosurgical Navigation is currently in effect and applies to covered operators in the named jurisdiction.
What types of robots does FDA 510(k) Clearance: Zeta Surgical Zeta Navigation System for Neurosurgical Navigation apply to?
FDA 510(k) Clearance: Zeta Surgical Zeta Navigation System for Neurosurgical Navigation is recorded as applying to surgical on the DEPLOY registry.
Which robot models on the DEPLOY registry fall under FDA 510(k) Clearance: Zeta Surgical Zeta Navigation System for Neurosurgical Navigation?
8 robot models on the DEPLOY registry match the form-factor scope of FDA 510(k) Clearance: Zeta Surgical Zeta Navigation System for Neurosurgical Navigation: ANOVO, Andromeda Surgical Robot, CORI, Carina and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.
Primary Sources & Legal Instruments
1 document- https://www.todaysmedicaldevelopments.com/news/regulatory-roundup-may-2026/Official Source
https://www.todaysmedicaldevelopments.com/news/regulatory-roundup-may-2026/