MEDTRONIC NAVIGATION, INC.

FDA Device Registration & Listing · Lafayette, CO, US · Registration 1723170

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1723170
FEI Number
1000517638
Entity Name
MEDTRONIC NAVIGATION, INC.
City/State/Country
Lafayette, CO, US
Establishment Address
200 Medtronic Drive, Lafayette, CO 80026, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Medtronic, Inc. (Owner Number: 2112641)
Owner / Operator Contact Address
710 Medtronic Parkway, Minneapolis, MN 55432, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190672
PMA Number
N/A

All Registered Proprietary Names

Stealth AXiS™ ENT Clinical Application STEALTH AXIS™ Visualase StealthStation Universal Attachment StealthStation Fluoro Nav Module FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM Navigated CD HORIZON SOLERA Screwdrivers and Taps CD HORIZON SOLERA Spinal System PlasmaBlade X 3S LIGHT Navlock Black and Blue Trackers Stealth Viz Software Visualase Thermal Therapy System Aquamantys SBS 5 Sheathed Bipolar Sealer (23-312-1) Aquamantys Mini EVS 3.4 Epidural Vein Sealer (23-314-1) Aquamantys Epidural Vein Sealer (23-121-1) Aquamantys 2.3 Bipolar Sealer (23-113-1); StealthStation Advanced Contour Registration StealthStation Cranial Software, v3.1.5 (9735585) StealthStation Orthopaedic Trauma Stealth™ Spine Clamps ModuLeX™ Shank Mounts O-arm Equipment Drape Surgical drape and drape accessories StealthStation S8 ENT Software Stealthstation S8 Spine Software v1.3 Immerge Image Correlation V2 VISUALASE THERMAL THERAPY SYSTEM PEAK PlasmaBlade 3S (Model Number: PS210-030S, PS210-030S-SP, PS210-030SE) StealthStation (Drill attachment) NavLock Trackers Polestar N-20 StealthStation Cranial Software v1.3 GoldenEye Micro-Magnetic Tracking Mazor X Visualase™ V2 MRI-Guided Laser Ablation System O-arm™ O2 imaging system StealthStation Imageless Knee Module StealthStation FlexENT StealthStation S8 ENT Software 1.3 StealthStation AxiEM Imageless Knee Module Manual surgical instrument for general use Slap Hammer AQUAMANTYS SS4 BIPOLAR SEALER, MODEL 23-121-1 StealthStation System StealthConnect Remote Viewing, Planning and Collaboration System StealthStation S8 Spine Software Ziehm StealthStation™ Spinous Process Clamps O-Arm O2 Imaging System StealthStation ENT Application neurological stereotaxic instrument StealthStation System with StealthStation Cranial Software O-Arm Imaging System StealthStation Hip Module StealthStation AxiEM Imageless Hip Visualase (9735563) PEAK PlasmaBlade Tonsil (PS300-001, PS300-001E, PS300-003, SP300-003E) StealthStation S8 Cranial v2 Mazor X System Mazor X Stealth Edition Steritite Sealed Containers StealthStation Cranial Software v3.1.1 StealthStation Synergy Cranial S7 Software v.2.2.8,

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2014-05-23
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2010-06-07
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-05-22
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1994-11-09
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2010-08-18
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2011-01-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2014-06-05
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2014-06-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-08-21
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2013-08-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-03-30
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-06-19
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2011-01-27
FRN Pump, Infusion General Hospital Class 2 880.5725 2020-05-26
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-05-26
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-05-26
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2013-10-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-05-23
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2007-12-12
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2011-01-27
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2023-12-14
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2011-01-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-09-29
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2017-12-05
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2017-05-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-07-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2011-01-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2015-02-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2015-02-11
FRN Pump, Infusion General Hospital Class 2 880.5725 2015-02-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-28
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2011-01-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-01-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2007-12-10
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2020-06-25
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2012-11-27
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2010-03-19
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2009-12-30
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-11-10
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-11-10
ONO Neurosurgical Laser With Mr Thermography General, Plastic Surgery Class 2 878.4810 2025-06-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-28
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-08-16
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2024-08-16
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-08-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2010-11-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-04-10
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2011-01-27
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2011-01-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-04-10
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2020-07-01
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2011-01-27
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 1994-11-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-04-10
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2007-12-12
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2018-11-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-11-12
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2018-03-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-03-07
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2010-12-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-05-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-07-25
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-08-09
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2020-10-15
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2020-10-15
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2020-10-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2011-01-27
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2016-09-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-06-13
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2006-03-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-09-13
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2011-01-27
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2015-06-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-04-10
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2015-08-17
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2015-08-17
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2015-08-17
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2011-01-27
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 1992-12-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-28
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2023-12-19
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2010-05-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-11-30
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-11-17
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-11-17
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2011-12-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-04-10
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2009-12-30
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2010-04-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-05-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-04-10
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-08-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007042319 HeartWare, Inc. Miami Lakes, FL, US
3004497303 MEDTRONIC MEXICO EG EMPALME Sonora, MX
3015192387 CATHWORKS Newport Beach, CA, US
3004185781 Medtronic, Inc. Tempe, AZ, US
3012520654 MEDTRONIC, INC. Billerica, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K111339 Medtronic, Inc. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 2011-06-08
K200041 Fiagon GmbH FlexPointer 1.5 Single Use, FlexTube 3 Single Use 2020-03-10
K033504 General Electric Co. GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM 2003-11-25
K013636 GE Medical Systems SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 2002-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0029-2007 Hitachi Medical Systems America Inc 2
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014 Philips Medical Systems (Cleveland) Inc 2
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1723170. Last updated year: 2026. Please use registration number 1723170 when referencing this establishment in official correspondence.
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