Medical Device Manufacturer · US , Lafayette , CO

Medtronic Navigation, Inc. - FDA 510(k) Cleared Devices

35 submissions · 35 cleared · Since 2005

Recent clearances: Stealth AXiS Cranial clinical application, Stealth AXiS™ ENT clinical application, Visualase Cooled Laser Applicator System (9735559)

Official Website

35

Total

35

Cleared

0

Denied

FDA 510(k) Regulatory Record - Medtronic Navigation, Inc. Orthopedic ✕

6 devices

1-6 of 6

Cleared Feb 12, 2026

Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application

Orthopedic · 135d

Cleared Oct 17, 2025

StealthStation S8 Spine Software

Orthopedic · 176d

Cleared Jun 05, 2025

Stealth™ Spine Clamps

Orthopedic · 290d

Cleared May 29, 2020

Stealthstation S8 Spine Software v1.3.0

Orthopedic · 28d

Cleared Aug 14, 2013

NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER

Orthopedic · 89d

Cleared Mar 22, 2013

NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS

Orthopedic · 86d