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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2026-02-12 under 510(k) 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. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K253381.

When did Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application receive FDA 510(k) clearance?

Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application received FDA 510(k) clearance on 2026-02-12, under 510(k) number K253381.

Who is the listed applicant for Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Medtronic Navigation, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253379Stealth AXiS Cranial clinical applicationK253395Stealth AXiS™ ENT clinical applicationK253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)K251282StealthStation S8 Spine SoftwareK242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsK250307Visualase V2 MRI-guided Laser Ablation System (9736422)

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Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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.

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