FDA.reportPublic FDA data

510(k) K253381

Device
Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
Applicant
Medtronic Navigation, Inc.
510(k) number
K253381
Product code
OLO
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-12
Date received
2025-09-30
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Victoria Baldock
Address
200 Medtronic Dr. Lafayette CO US 80026 80026

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OLO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261852OTS HipOrtoma AB2026-07-01
K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH2026-06-26
K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC2026-06-25
K260369Dynamis Robotic Surgical SystemLEM Surgical AG2026-06-20
K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.2026-06-18
K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.2026-06-02
K261060Navigated LLIF Impactable TrackerTyber Medical, LLC2026-05-29
K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL2026-05-26
K260329Ion-C Navigation InstrumentsSurGenTec, LLC2026-05-22
K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS2026-05-21
K252880Pytheas Your Guided TrajectoryPytheas Navigation Sas2026-05-11
K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.2026-04-16
K254158SPINEART Navigation Instrument SystemSpineart SA2026-04-09
K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL2026-03-27
K260601REAL INTELLIGENCE™ CORI™Blue Belt Technologies, Inc.2026-03-26