Stealth AXiS Surgical System with Stealth AXiS Spine clinical application
K-Number: K253381 · 2026-02-12
ApplicantMedtronic Navigation, Inc.
Decision Date2026-02-12
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Stealth AXiS Surgical System with Stealth AXiS Spine clinical application is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2026-02-12 under approval number K253381. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Stealth AXiS Surgical System with Stealth AXiS Spine clinical application?
Stealth AXiS Surgical System with Stealth AXiS Spine clinical application is a medical device that received FDA 510(k) clearance on 2026-02-12. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K253381.
When was Stealth AXiS Surgical System with Stealth AXiS Spine clinical application approved by the FDA?
Stealth AXiS Surgical System with Stealth AXiS Spine clinical application received FDA 510(k) clearance on 2026-02-12, under approval number K253381.
What company makes Stealth AXiS Surgical System with Stealth AXiS Spine clinical application?
Stealth AXiS Surgical System with Stealth AXiS Spine clinical application is manufactured by Medtronic Navigation, Inc..
What is the FDA product code for Stealth AXiS Surgical System with Stealth AXiS Spine clinical application?
The FDA product code for Stealth AXiS Surgical System with Stealth AXiS Spine clinical application is OLO.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.