Neurological Stereotaxic Instrument

FDA product code HAW · 410 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.4560
Review panel: NE
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-04-05 – 2026-09-10

HAW 2026-09-10

Geniant Cranial (Navigated Neurosurgical Positioning Robot)

Applicant Koh Young Technology, Inc.

K number K253856

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HAW 2026-08-05

Leksell® Vantage Stereotactic System

Applicant Elekta Solutions AB

K number K261932

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HAW 2026-05-01

Zeta Navigation System

Applicant Zeta Surgical, Inc.

K number K253663

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HAW 2026-03-26

Stealth AXiS Cranial clinical application

Applicant Medtronic Navigation, Inc.

K number K253379

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HAW 2025-10-21

NeuroAlign software

Applicant Medivis, Inc.

K number K231897

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HAW 2025-09-05

SOLOPASS 2.0 System

Applicant Intravent Medical Partners

K number K251317

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HAW 2025-09-04

Ball Joint Guide Array (66295)

Applicant Bayer Medical Care, Inc.

K number K250893

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HAW 2025-07-09

EZ-FIDUCIALS

Applicant Phasor Health, LLC

K number K250505

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HAW 2025-05-23

Stereotaxic Guiding Surgical Devices, NaoTrac S

Applicant Brain Navi Biotechnology Co., Ltd.

K number K242575

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HAW 2025-02-05

Navient Image Guide Navigation System (955-NC-NC), Cranial

Applicant Claronav

K number K241327

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HAW 2025-01-28

Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT

Applicant Brainlab AG

K number K243698

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HAW 2025-01-24

ClearPoint System (Software Version 3.0)

Applicant ClearPoint Neuro, Inc.

K number K243657

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HAW 2025-01-17

Geniant Cranial (Navigated Neurosurgical Positioning Robot)

Applicant Koh Young Technology, Inc.

K number K241333

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HAW 2024-12-27

FLASH EVD System (10-0002)

Applicant 7D Surgical ULC

K number K242480

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HAW 2024-10-04

Zeta Cranial Navigation System (ZNS131-US)

Applicant Zeta Surgical, Inc.

K number K242351

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HAW 2024-04-26

Bone Anchor (NGS-BA-01)

Applicant ClearPoint Neuro, Inc.

K number K233703

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HAW 2024-01-12

ClearPointer Optical Navigation Wand

Applicant ClearPoint Neuro, Inc.

K number K233155

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HAW 2024-01-12

ClearPoint Bone Screw Fiducials

Applicant ClearPoint Neuro, Inc.

K number K233144

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HAW 2024-01-12

SmartFrame OR

Applicant ClearPoint Neuro, Inc.

K number K233141

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HAW 2024-01-10

Zeta Cranial Navigation System (ZNS131-US)

Applicant Zeta Surgical, Inc.

K number K233903

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HAW 2023-11-27

ClearPoint System (Software Version 2.2)

Applicant ClearPoint Neuro, Inc.

K number K233243

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HAW 2023-10-19

StealthStation Cranial Software, v3.1.5 (9735585)

Applicant Medtronic Navigation, Inc.

K number K231976

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HAW 2023-09-15

ClearPoint Array System (Version 1.2)

Applicant ClearPoint Neuro, Inc.

K number K232102

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HAW 2023-09-09

Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial

Applicant Brainlab AG

K number K223864

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HAW 2023-09-08

Zeta Cranial Navigation System

Applicant Zeta Surgical

K number K230661

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HAW 2023-07-21

Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

Applicant Brainlab AG

K number K223288

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HAW 2023-07-20

ROSA ONE Brain Application

Applicant Medtech S.A.S

K number K231103

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HAW 2023-07-14

NaviNetics Reusable Stereotactic System (NN1000)

Applicant Navinetics, Inc.

K number K231392

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HAW 2023-06-18

Sinobot X1

Applicant Sinovation (Beijing) Medical Technology Co., Ltd.

K number K220072

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HAW 2023-04-19

Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial

Applicant Brainlab AG

K number K223552

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HAW 2023-04-17

Localite TMS Navigator TS

Applicant Localite GmbH

K number K223577

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HAW 2023-03-17

MagVenture TMS Atlas Neuro Navigation System

Applicant Tonica Elektronik A/S

K number K221544

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HAW 2023-02-22

Disposable Pre-calibrated Brain Biopsy Needle 2.0

Applicant PAJUNK GmbH Medizintechnologie

K number K230201

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HAW 2023-02-16

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System

Applicant Stryker Corporation

K number K212194

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HAW 2022-09-16

ClearPoint System

Applicant ClearPoint Neuro, Inc.

K number K222519

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HAW 2022-09-08

Cranial EM System

Applicant Brainlab AG

K number K213989

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HAW 2022-08-17

Disposable Brain Biopsy Needle 2.0

Applicant PAJUNK GmbH Medizintechnologie

K number K220897

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HAW 2022-06-10

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4

Applicant Medtronic Navigation, Inc.

K number K221087

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HAW 2022-05-04

ROSA ONE Brain application

Applicant Medtech S.A.S

K number K214065

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HAW 2022-04-12

ClearPoint Array System (version 1.1)

Applicant ClearPoint Neuro, Inc.

K number K214040

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HAW 2022-04-08

visor2 system

Applicant Eemagine Medical Imaging Solutions GmbH

K number K210109

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HAW 2021-12-22

StealthStation S8 Cranial v2.0

Applicant Medtronic Navigation

K number K212397

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HAW 2021-12-03

Molecular Flow Simulations

Applicant Therataxis, LLC

K number K201435

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HAW 2021-11-12

Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System

Applicant Brainlab AG

K number K210989

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HAW 2021-11-03

Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization

Applicant Brainlab AG

K number K211544

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HAW 2021-08-27

SOLOPASS System

Applicant Intravent Medical Partners, LP

K number K203251

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HAW 2021-06-17

NaviNetics D1 Stereotactic System

Applicant Navinetics, Inc.

K number K210700

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HAW 2021-01-29

Disposable Pre-calibrated Suction

Applicant Brainlab AG

K number K201752

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HAW 2021-01-22

ClearPoint Array System

Applicant ClearPoint Neuro, Inc.

K number K202575

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HAW 2021-01-13

StealthStation Cranial Software v1.3.2

Applicant Medtronic Navigation, Inc.

K number K203639

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HAW 2020-10-08

Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update

Applicant Brainlab AG

K number K192703

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HAW 2020-06-03

StealthStation Cranial Software v1.3.0

Applicant Medtronic Navigation, Inc.

K number K201175

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HAW 2020-05-29

ROSA ONE Brain application

Applicant Medtech S.A

K number K200511

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HAW 2020-04-06

Neural Navigator

Applicant Soterix Medical, Inc.

K number K191422

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HAW 2020-02-13

ClearPoint System and Accessories

Applicant Mri Interventions, Inc.

K number K200079

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HAW 2019-11-27

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application

Applicant 7D Surgical, Inc.

K number K192945

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HAW 2019-11-01

Stealth Autoguide System, Midas Rex Legend Depth Stop System

Applicant Medtronic Navigation, Inc.

K number K191597

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HAW 2019-09-06

Microscope Navigation

Applicant Brainlab AG

K number K190250

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HAW 2019-08-07

7D Surgical System

Applicant 7D Surgical, Inc.

K number K183276

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HAW 2019-08-01

Leksell Vantage Stereotactic System

Applicant Elekta Instrument AB

K number K190887

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HAW 2019-07-31

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1

Applicant Medtronic Navigation, Inc.

K number K190672

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HAW 2019-07-14

Modus Nav

Applicant Synaptive Medical, Inc.

K number K183325

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HAW 2019-06-21

Voyager Trajectory Array Guide (V-TAG)

Applicant Mri Interventions, Inc.

K number K191400

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HAW 2019-02-07

ROSA ONE Brain Application

Applicant Medtech S.A

K number K182417

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HAW 2019-01-29

AQrate Robotic Assistance System

Applicant Globus Medical, Inc.

K number K182000

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HAW 2018-08-08

7D Surgical System Cranial Application

Applicant 7D Surgical, Inc.

K number K181041

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HAW 2018-07-26

neuromate Gen III

Applicant Renishaw Mayfield Sarl

K number K181706

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HAW 2018-07-23

Voyager Trajectory Array Guide (V-TAG)

Applicant Voyager Therapeutics, Inc.

K number K180854

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HAW 2018-04-24

neuromate Gen III

Applicant Renishaw Mayfield Sarl

K number K180206

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HAW 2018-03-28

ROSA BRAIN (v3.0.0.5)

Applicant Medtech S.A

K number K172444

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HAW 2018-03-01

Microscope Navigation Software

Applicant Brainlab AG

K number K172820

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HAW 2017-09-15

Leksell Vantage Stereotactic System

Applicant Elekta Instrument AB

K number K171123

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HAW 2017-09-15

neuro inspire

Applicant Rensihaw Plc

K number K163666

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HAW 2017-09-14

Fiagon Navigation System

Applicant Fiagon GmbH

K number K163209

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HAW 2017-09-01

NaviENT

Applicant Claronav, Inc.

K number K163439

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HAW 2017-04-21

StealthConnect Remote Viewing, Planning and Collaboration System

Applicant Medtronic Navigation, Inc.

K number K162655

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HAW 2017-03-31

StealthStation S8 System Platforms and StealthStation Cranial Software

Applicant Medtronic Navigation, Inc.

K number K162309

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HAW 2017-02-22

Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker

Applicant Stryker Corporation

K number K162929

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HAW 2016-12-30

Cranial Reducing Tubes

Applicant Medtronic Navigation, Inc.

K number K162604

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HAW 2016-12-06

CRW STEREOTACTIC SYSTEM

Applicant Integra LifeSciences Corporation

K number K160811

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HAW 2016-09-14

StealthStation System with Cranial Software

Applicant Medtronic Navigation, Inc.

K number K153660

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HAW 2016-07-13

EXACTECH GPS

Applicant Blue Ortho

K number K152764

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HAW 2016-06-24

BrightMatter Guide with BrightMatter Pointer

Applicant Synaptive Medical, Inc.

K number K160523

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HAW 2016-04-01

Fiagon Navigation System

Applicant Fiagon GmbH

K number K151156

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HAW 2016-03-30

BrightMatter Guide with Surface Trace Registration

Applicant Synaptive Medical, Inc.

K number K153281

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HAW 2016-03-17

ClearPoint System

Applicant Mri Interventions, Inc.

K number K160434

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HAW 2016-03-02

Leksell Stereotactic System, Injection/ Aspiration Needle Kit

Applicant Elekta Instrument AB

K number K152558

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HAW 2013-10-18

CRANIAL MAP NEURO

Applicant Stryker Corporate

K number K131214

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HAW 2013-09-27

STRYKER NAV3I PLATFORM

Applicant Stryker Corporate

K number K130874

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HAW 2013-08-07

QUADCUT

Applicant Medtronic Navigation, Inc.

K number K130608

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HAW 2012-12-17

SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS

Applicant Synthes Spine

K number K122211

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HAW 2012-09-27

KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM

Applicant KARL STORZ Endoscopy-America, Inc.

K number K122096

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HAW 2012-07-26

MICROTARGETING XL STAR DRIVE SYSTEM

Applicant FHC, Inc.

K number K121950

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HAW 2012-07-12

RENAISSANCE

Applicant Mazor Robotics , Ltd.

K number K120812

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HAW 2012-05-24

PRAEZIS PLUS

Applicant Tatramed Spol. S.R.O.

K number K110644

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HAW 2012-04-24

BRAIN BIOPSY NEEDLE

Applicant Ad-Tech Medical Instrument Corp

K number K112094

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HAW 2012-03-27

SURGICASE GUIDE

Applicant Materialise NV

K number K111558

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HAW 2012-03-23

GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM

Applicant Sonowand AS

K number K112469

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HAW 2011-12-01

RENAISSANCE SYSTEM

Applicant Mazor Robotics , Ltd.

K number K113228

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HAW 2011-06-03

IPLAN

Applicant Brainlab AG

K number K101627

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