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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K253381

Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application · Medtronic Navigation, Inc. · decided 2026-02-12 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Stealth AXiS9736481MEDTRONIC NAVIGATION, INC.OLO00763000984441
Stealth AXiS9736669MEDTRONIC NAVIGATION, INC.OLO00763000995379
Stealth AXiS9736675MEDTRONIC NAVIGATION, INC.OLO00763000995249
Stealth AXiS9736691MEDTRONIC NAVIGATION, INC.OLO00763000994495
Stealth AXiS9736513MEDTRONIC NAVIGATION, INC.OLO00763000928889
Stealth AXiS9736680MEDTRONIC NAVIGATION, INC.OLO00763000983888
Stealth AXiS9736665MEDTRONIC NAVIGATION, INC.OLO00763000995423
Stealth AXiS9736483MEDTRONIC NAVIGATION, INC.OLO00763000984465
Stealth AXiS9736667MEDTRONIC NAVIGATION, INC.OLO00763000995300
Stealth AXiS9736666MEDTRONIC NAVIGATION, INC.OLO00763000995287
Stealth AXiS9736764MEDTRONIC NAVIGATION, INC.OLO00199150071586
Stealth AXiS9736482MEDTRONIC NAVIGATION, INC.OLO00763000984458
Stealth AXiS9736484MEDTRONIC NAVIGATION, INC.OLO00763000984472
Stealth AXiS9736520MEDTRONIC NAVIGATION, INC.OLO00763000945947
Stealth AXiS9736485MEDTRONIC NAVIGATION, INC.OLO00763000984489
Stealth AXiS9736670MEDTRONIC NAVIGATION, INC.OLO00763000995201
Stealth AXiS9736521MEDTRONIC NAVIGATION, INC.OLO00763000928919
Stealth AXiS9736672MEDTRONIC NAVIGATION, INC.OLO00763000995188
Stealth AXiS9736681MEDTRONIC NAVIGATION, INC.OLO00763000998493
Stealth AXiS9736533MEDTRONIC NAVIGATION, INC.OLO00763000928926
Stealth AXiS9736671MEDTRONIC NAVIGATION, INC.OLO00763000995225
Stealth AXiS9736664MEDTRONIC NAVIGATION, INC.OLO00763000995409
Stealth AXiS9736766MEDTRONIC NAVIGATION, INC.OLO00199150071609
Stealth AXiS9736512MEDTRONIC NAVIGATION, INC.OLO00763000928865
Stealth AXiS9736486MEDTRONIC NAVIGATION, INC.OLO00763000984496