Stealth AXiS Surgical System with Stealth AXiS Spine clinical application— 510(k) K253381
Substantially EquivalentMedtronic 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.
Summary
Medtronic Navigation's Stealth AXiS Surgical System with Stealth AXiS Spine clinical application is filed under product code OLO, orthopedic stereotaxic instrument. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
Medtronic Navigation filed from Lafayette, Colorado. The decision came 135 calendar days after FDA received it (September 30, 2025 to February 12, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Medtronic Navigation, Inc.
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lafayette, CO, US
Recent devices under product code OLO
view all- K263154 — CarboClear® Cervical Navigated Instruments
- K262257 — Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine
- K262506 — Remex Spine Surgery Navigation - Universal Instruments
- K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))
- K261205 — SPINEART Navigation Instrument System
More clearances from Medtronic Navigation, Inc.
view allAdverse 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, through . 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.