FDA 510(k) clearance · back to tracker
Stealth AXiS Surgical System with Stealth AXiS Spine clinical application
Medtronic Navigation, Inc. cleared K253381 on 2026-02-12, decision: substantially equivalent
K-number
K253381
Sponsor
Medtronic Navigation, Inc.
Device
Stealth AXiS Surgical System with Stealth AXiS Spine clinical application
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-02-12
Product code
OLO
Advisory committee
Neurology
Medical specialty
Neurology
Regulation number
882.4560
Official FDA record
Open K253381on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
openFDA JSON
Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
Use this as a predicate
Drop K253381 into Compass and start a substantial-equivalence draft.
Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.
Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.