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 2004-08-23

VECTORVISION HIP 3.0

Applicant Brainlab AG

K number K040368

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HAW 2004-07-23

ELEKTA MICRODRIVE, MODEL 916716

Applicant Elekta Instrument AB

K number K040979

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HAW 2004-07-08

ACUMEN SURGICAL NAVIGATION SYSTEM

Applicant Biomet, Inc.

K number K031454

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HAW 2004-06-22

NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017

Applicant Orthosoft, Inc.

K number K041369

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HAW 2004-06-03

NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000

Applicant Image-Guided Neurologics, Inc.

K number K040834

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HAW 2004-03-11

NAVIPRO KNEE SOFTWARE MODULE

Applicant Kinamed, Inc.

K number K033668

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HAW 2004-03-02

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000

Applicant Image-Guided Neurologics, Inc.

K number K033619

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HAW 2004-02-18

ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS

Applicant Zimmer, Inc.

K number K033223

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HAW 2004-02-17

VECTORVISION CRANIAL/ENT

Applicant Brainlab AG

K number K023651

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HAW 2004-02-12

LEKSELL SURGIPLAN WITH IMAGEMERGE

Applicant Elekta Instrument AB

K number K033340

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HAW 2004-02-12

ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS

Applicant Zimmer, Inc.

K number K033011

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HAW 2004-01-27

NDI PASSIVE SPHERES

Applicant Northern Digital, Inc.

K number K033621

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HAW 2004-01-07

SPINEASSIST DEVICE

Applicant Mazor Surgical Technologies , Ltd.

K number K033413

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HAW 2003-10-21

NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE

Applicant Orthosoft, Inc.

K number K032917

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HAW 2003-10-15

EBI ACUMEN SURGICAL NAVIGATION SYSTEM

Applicant Ebi, L.P.

K number K031732

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HAW 2003-09-15

RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE

Applicant Radionics, A Division of Tyco Healthcare Group LP

K number K032054

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HAW 2003-09-15

ACUMEN SURGICAL NAVIGATION SYSTEM

Applicant Biomet, Inc.

K number K031337

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HAW 2003-08-12

CI TKR/UKR

Applicant Brainlab AG

K number K031770

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HAW 2003-07-25

ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT

Applicant Elekta Instrument AB

K number K031999

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HAW 2003-07-25

MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM

Applicant Elekta Instrument AB

K number K031980

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HAW 2003-06-11

VECTORVISION FLUORO3D

Applicant Brainlab AG

K number K024192

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HAW 2003-06-02

STRYKER NAVIGATION SYSTEM-KNEE MODULE

Applicant Stryker Leibinger

K number K022579

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HAW 2003-05-23

NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204

Applicant Orthosoft, Inc.

K number K030827

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HAW 2003-05-09

NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005

Applicant Orthosoft, Inc.

K number K031156

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HAW 2003-05-09

IGI-SYSTEM

Applicant Denx Advanced Dental Systems

K number K023424

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HAW 2003-05-02

DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE

Applicant Gyrus Ent LLC

K number K030343

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HAW 2003-04-24

Z-BOX

Applicant Z-Kat, Inc.

K number K030764

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HAW 2003-03-19

IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM

Applicant Medtronic Surgical Navigation Technologies

K number K030552

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HAW 2003-03-12

NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000

Applicant Image-Guided Neurologics, Inc.

K number K024201

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HAW 2003-02-25

NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES

Applicant Image-Guided Neurologics, Inc.

K number K023949

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HAW 2003-02-12

STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE

Applicant Medtronic Surgical Navigation Technologies

K number K030106

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HAW 2003-02-04

NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200

Applicant Orthosoft, Inc.

K number K022364

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HAW 2003-01-22

STRYKER NAVIGATION SYSTEM - HIP MODULE

Applicant Stryker Instruments

K number K022365

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HAW 2003-01-03

CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM

Applicant Medtronic Surgical Navigation Technologies

K number K022126

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HAW 2002-12-20

VOYAGER LINUX

Applicant Z-Kat, Inc.

K number K023975

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HAW 2002-12-09

SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS

Applicant Smith & Nephew, Inc.

K number K021798

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HAW 2002-11-19

HIP MODULE FOR THE STEALTHSTATION SYSTEM

Applicant Medtronic Surgical Navigation Technologies

K number K021980

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HAW 2002-10-25

VECTORVISION CT-FREE KNEE

Applicant Brainlab AG

K number K021306

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HAW 2002-10-17

SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS

Applicant Smith & Nephew, Inc.

K number K021815

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HAW 2002-09-25

NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010

Applicant Image-Guided Neurologics, Inc.

K number K022100

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HAW 2002-09-09

IPLAN

Applicant Brainlab AG

K number K020631

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HAW 2002-08-27

NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120

Applicant Orthosoft, Inc.

K number K021760

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HAW 2002-08-19

SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS

Applicant Smith & Nephew, Inc.

K number K022460

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HAW 2002-08-14

STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE

Applicant Medtronic Surgical Navigation Technologies

K number K022414

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HAW 2002-08-13

SPHERZ

Applicant I.Z.I. Corp.

K number K022074

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HAW 2002-08-07

ALPHA DRIVE SYSTEM

Applicant Alpha Omega , Ltd.

K number K013396

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HAW 2002-07-25

ORTHOPILOT HTO MODULE

Applicant Aesculap, Inc.

K number K021327

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HAW 2002-07-19

KOLIBRI IGS SYSTEMS

Applicant Brainlab AG

K number K014256

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HAW 2002-06-14

ENDOMAP

Applicant Siemens Medical Solutions USA, Inc.

K number K014113

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HAW 2002-06-03

NAVIPRO

Applicant Kinamed, Inc.

K number K020764

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HAW 2002-05-20

GALILEO CAS/NAV TKR SYSTEM

Applicant Plus Orthopedics

K number K020298

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HAW 2002-04-04

ORTHOPILOT 2

Applicant Aesculap, Inc.

K number K013569

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HAW 2002-04-04

MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM

Applicant Ohio Medical Instrument Co., Inc.

K number K013428

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HAW 2002-03-14

VECTORVISION TRAUMA

Applicant Brainlab AG

K number K012448

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HAW 2002-02-27

STEALTHSTATION WITH FLUOROMERGE SOFTWARE

Applicant Medtronic Surgical Navigation Technologies

K number K020338

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HAW 2002-02-08

SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS

Applicant Smith & Nephew, Inc.

K number K012938

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HAW 2002-01-25

KNEE MODULE FOR THE STEALTHSTATION SYSTEM

Applicant Medtronic Surgical Navigation Technologies

K number K012937

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HAW 2001-12-20

3D LINE STEROTACTIC HARDWARE ACCESSORIES

Applicant 3D Line USA, Inc.

K number K011255

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HAW 2001-12-06

MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE

Applicant Elekta Instrument AB

K number K013861

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HAW 2001-12-03

MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY

Applicant Stryker Leibinger

K number K012380

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HAW 2001-10-30

HEMI-ARC SURGICAL NAVIGATOR

Applicant Nuvasive, Inc.

K number K013257

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HAW 2001-10-22

NAVIGUS II MR

Applicant Image-Guided Neurologics, Inc.

K number K012719

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HAW 2001-10-09

CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE

Applicant Cbyon, Inc.

K number K012886

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HAW 2001-10-03

MODIFICATION TO FLOUROLAB PLUS

Applicant Z-Kat, Inc.

K number K013025

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HAW 2001-10-01

NAVIGUS II TRAJECTORY GUIDE

Applicant Image-Guided Neurologics, Inc.

K number K012366

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HAW 2001-09-12

VECTORVISION HIP

Applicant Brainlab AG

K number K010602

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HAW 2001-09-06

MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM

Applicant Brainlab AG

K number K012564

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HAW 2001-09-06

VECTORVISION KNEE

Applicant Brainlab AG

K number K010612

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HAW 2001-08-31

STRYKER NAVIGATION SYSTEM-KNEE MODULE

Applicant Stryker Corp.

K number K010204

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HAW 2001-08-30

MICRO TARGETING DRIVE SYSTEM

Applicant FHC, Inc.

K number K011775

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HAW 2001-08-30

VECTORVISION CT/FLUORO

Applicant Brainlab AG

K number K010968

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HAW 2001-08-14

FHC MICROTARGETING DRIVE SYSTEM

Applicant FHC, Inc.

K number K011992

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HAW 2001-08-03

NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000

Applicant Image-Guided Neurologics, Inc.

K number K011971

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HAW 2001-05-21

VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT

Applicant Brainlab AG

K number K003589

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HAW 2001-05-17

STEREOTACTIC FRAME BASED SYSTEM

Applicant Stryker Instruments

K number K003486

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HAW 2001-05-08

SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION

Applicant Surgical Navigation Specialists, Inc.

K number K010542

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HAW 2001-03-15

LORENZ FIDUCAIL SCREW

Applicant Walter Lorenz Surgical, Inc.

K number K010427

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HAW 2001-03-12

MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)

Applicant Radionics, A Division of Tyco Healthcare Group LP

K number K010548

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HAW 2001-02-27

MEDIVISION IGS SYSTEM

Applicant Medivision (U.S.A.), Inc.

K number K003699

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HAW 2001-02-23

MICROTARGETING DRIVE SYSTEM

Applicant FHC, Inc.

K number K003776

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HAW 2001-02-23

ORTHOPILOT

Applicant Kinamed, Inc.

K number K003347

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HAW 2001-02-22

Z-TOUCH

Applicant Brainlab AG

K number K003268

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HAW 2001-01-24

STRYKER REMOTE SURGICAL PLANNING SYSTEM

Applicant Stryker Instruments

K number K004027

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HAW 2001-01-04

STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES

Applicant Stryker Instruments

K number K003111

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HAW 2000-12-12

STEALTHSTATION TREATMENT GUIDANCE PLATFORM

Applicant Medtronic Surgical Navigation Technologies

K number K003201

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HAW 2000-12-04

FLUOROLAB PLUS

Applicant Z-Kat, Inc.

K number K002893

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HAW 2000-10-02

STRYKER NAVIGATION SYSTEM - ENT MODULE

Applicant Stryker Corp.

K number K002732

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HAW 2000-09-12

INSIGHT IMAGE GUIDED SURGICAL SYSTEM

Applicant Surgical Insights, Inc.

K number K001642

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HAW 2000-08-03

NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004

Applicant Orthosoft, Inc.

K number K002053

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HAW 2000-07-26

OPTICAL TRACKING SYSTEM (OTS)

Applicant Radionics, Inc.

K number K001950

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HAW 2000-06-30

STEATHSTATION TREATMENT GUIDANCE PLATFORM

Applicant Medtronic Surgical Navigation

K number K001801

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HAW 2000-06-12

STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM

Applicant Medtronic Surgical Navigation Technologies

K number K001284

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HAW 2000-06-07

SELF ADHERING NAVIGUS GUIDE

Applicant Image-Guided Neurologics, Inc.

K number K001192

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HAW 2000-05-17

MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)

Applicant Radionics, Inc.

K number K001431

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HAW 2000-05-03

MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM

Applicant Medtronic Surgical Navigation

K number K001153

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HAW 2000-03-13

CBYON SURGICAL OPERATING SYSTEM (SOS)

Applicant Cbyon, Inc.

K number K000171

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HAW 2000-02-23

SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION

Applicant Surgical Navigation Specialists, Inc.

K number K994421

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HAW 2000-02-22

STEALTHSTATION TREATMENT GUIDANCE PLATFORM

Applicant Surgical Navigation Technologies, Inc.

K number K992461

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HAW 2000-02-15

VOYAGER 6.0 SOFTWARE OPTION

Applicant Philips Medical Systems (Cleveland), Inc.

K number K000310

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HAW 2000-01-18

STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX

Applicant Stryker Corp.

K number K993239

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