FDA 510(k) Clearance: Medtronic Stealth AXiS Surgical System for Spine (Feb 2026)
[in effect]United States · permit · permit
Jurisdiction
United States
Classification
permit
Status
in effect
Effective Date
Feb 13, 2026
Primary Sources
1 audited
Statutory Scope & Summary
FDA cleared the Medtronic Stealth AXiS surgical system, the first integrated planning, navigation and robotics platform for spine surgery. Combines preoperative planning, intraoperative navigation, and robotic guidance.
Covered Sectors & Application Domains
Regulatory Analysis & Inquiries
6 entriesWhat does FDA 510(k) Clearance: Medtronic Stealth AXiS Surgical System for Spine (Feb 2026) cover?
FDA cleared the Medtronic Stealth AXiS surgical system, the first integrated planning, navigation and robotics platform for spine surgery. Combines preoperative planning, intraoperative navigation, and robotic guidance.
Where does FDA 510(k) Clearance: Medtronic Stealth AXiS Surgical System for Spine (Feb 2026) apply?
FDA 510(k) Clearance: Medtronic Stealth AXiS Surgical System for Spine (Feb 2026) is recorded as a permitting requirement applying in United States on the DEPLOY registry.
When did FDA 510(k) Clearance: Medtronic Stealth AXiS Surgical System for Spine (Feb 2026) take effect?
FDA 510(k) Clearance: Medtronic Stealth AXiS Surgical System for Spine (Feb 2026) is recorded as effective February 13, 2026 on the DEPLOY registry.
Is FDA 510(k) Clearance: Medtronic Stealth AXiS Surgical System for Spine (Feb 2026) still in effect?
FDA 510(k) Clearance: Medtronic Stealth AXiS Surgical System for Spine (Feb 2026) is currently in effect and applies to covered operators in the named jurisdiction.
What types of robots does FDA 510(k) Clearance: Medtronic Stealth AXiS Surgical System for Spine (Feb 2026) apply to?
FDA 510(k) Clearance: Medtronic Stealth AXiS Surgical System for Spine (Feb 2026) is recorded as applying to surgical on the DEPLOY registry.
Which robot models on the DEPLOY registry fall under FDA 510(k) Clearance: Medtronic Stealth AXiS Surgical System for Spine (Feb 2026)?
8 robot models on the DEPLOY registry match the form-factor scope of FDA 510(k) Clearance: Medtronic Stealth AXiS Surgical System for Spine (Feb 2026): 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://news.medtronic.com/2026-02-13-Medtronic-receives-FDA-clearance-for-Stealth-AXiS-TM-surgical-system,-first-integrated-planning,-navigation-and-robotics-platform-for-spine-surgeryOfficial Source
https://news.medtronic.com/2026-02-13-Medtronic-receives-FDA-clearance-for-Stealth-AXiS-TM-surgical-system,-first-integrated-planning,-navigation-and-robotics-platform-for-spine-surgery