# Medtronic Navigation, Inc.

- Location (FDA's records): Louisville, CO
- FDA decisions: 44 (2005–2026): 44 510(k) clearances
- Names in FDA's records: Medtronic Navigation, Inc. (35); Medtronic Navigation (9)
- Product codes: HAW (19), OLO (12), PGW (6), ONO (3), LLZ (2), GEI (1), OWB (1)
- 510(k) review time since 2016: median 118 days, against 115 for FDA's reviews in the same codes and years (17 of 31 faster)
- Predicates its devices cite: 73 (35 its own); citations of its devices by later devices: 118 (35 its own)
- Recalls linked to its devices: 36 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Surgical Navigation Technologies: 16 (https://510kreport.com/company/medtronic-surgical-navigation-technologies)
- Surgical Navigation Technologies, Inc.: 3 (https://510kreport.com/company/surgical-navigation-technologies)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic Powered Surgical Solutions: 2 (https://510kreport.com/company/medtronic-powered-surgical-solutions)
- Monteris Medical,: 2 (https://510kreport.com/company/monteris-medical)
- Image-Guided Neurologics, Inc.: 2 (https://510kreport.com/company/image-guided-neurologics)
- Mazor Robotics, Ltd.: 1 (https://510kreport.com/company/mazor-robotics)

## Firms that cite its devices most
- Medtronic Sofamor Danek USA, Inc.: 8 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Point Robotics MedTech, Inc.: 8 (https://510kreport.com/company/point-robotics-medtech)
- Brainlab AG: 6 (https://510kreport.com/company/brainlab)
- Fiagon GmbH: 4 (https://510kreport.com/company/fiagon)
- Stryker Corp.: 4 (https://510kreport.com/company/stryker)
- Globus Medical, Inc.: 3 (https://510kreport.com/company/globus-medical)
- 7D Surgical, Inc.: 3 (https://510kreport.com/company/7d-surgical)
- Zimmer Biomet Spine, Inc.: 2 (https://510kreport.com/company/zimmer-biomet-spine)

## Its most-cited devices
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps (2013), cited by 15
- K170011: StealthStation S8 Spine Software v1.0.0 (2017), cited by 11
- K162309: StealthStation S8 System Platforms and StealthStation Cranial Software (2017), cited by 9
- K133444: Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System (2014), cited by 9
- K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter (2013), cited by 8
- K201189: Stealthstation S8 Spine Software v1.3.0 (2020), cited by 8

## Recent decisions
- K253379: Stealth AXiS Cranial clinical application (Mar 26, 2026)
- K253395: Stealth AXiS™ ENT clinical application (Mar 16, 2026)
- K253391: Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) (Mar 13, 2026)
- K253381: Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (Feb 12, 2026)
- K251282: StealthStation S8 Spine Software (Oct 17, 2025)
- K242464: Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (Jun 5, 2025)
- K250307: Visualase V2 MRI-guided Laser Ablation System (9736422) (May 29, 2025)
- K240465: O-arm O2 Imaging System (Jun 21, 2024)

Source page: https://510kreport.com/company/medtronic-navigation