Stealth AXiS Surgical System with Stealth AXiS Spine clinical application— 510(k) K253381

Name: FDA 510(k) clearance K253381
Creator: U.S. Food and Drug Administration
Published: 2026-02-12

Substantially Equivalent

Medtronic Navigation, Inc.

FDA 510(k) clearance K253381 for Stealth AXiS Surgical System with Stealth AXiS Spine clinical application, Substantially Equivalent on 2026-02-12. Applicant: Medtronic Navigation, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Navigation, Inc.
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-09-30
Decision date: 2026-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLO

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K262506 — Remex Spine Surgery Navigation - Universal Instruments2026-08-20
K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
K261205 — SPINEART Navigation Instrument System2026-07-29
K261024 — TMINI Miniature Robotic System2026-07-24
K262121 — Ion-L Navigated Instruments2026-07-24

More clearances from Medtronic Navigation, Inc.

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K253379 — Stealth AXiS Cranial clinical application2026-03-26
K253395 — Stealth AXiS ENT clinical application2026-03-16
K253391 — Visualase Cooled Laser Applicator System (3 models)2026-03-13
K251282 — StealthStation S8 Spine Software2025-10-17
K242464 — Stealth Spine Clamps; ModuLeX Shank Mounts2025-06-05

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.