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Panels › Neurology › Product code HAW · Class 2

Neurological Stereotaxic Instrument

Regulation 882.4560

6510(k)s in 12 months (427 all time)
7recalls in 12 months (202 all time)
199recalls that name a 510(k)
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Top companies in HAW

DateFirm and productCodeLinked 510(k)
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - SpineMap 3D Module, Part number 6002-650-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle featu
Terminated
HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - iNtellect Cranial Planning Software - Enable, Part number 6000-652-300. It is part of the product series of the Stryker Navigation System. The system comprises software fo
Terminated
HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-652-000. It is part of the product series of the Stryker Navigation System. The system comprises software
Terminated
HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - iNtellect Cranial Navigation Software - Enable, Part number 6000-651-300. It is part of the product series of the Stryker Navigation System. The system comprises software
Terminated
HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - iNtellect Cranial Software - Maintenance, Part number 6000-651-200. It is part of the product series of the Stryker Navigation System. The system comprises software for pr
Terminated
HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - iNtellect Cranial Software - Upgrade, Part number 6000-651-100. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-op
Terminated
HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - iNtellect Cranial Software, Part number 6000-651-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative su
Terminated
HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-650-100. It is part of the product series of the Stryker Navigation System. The system comprises software
Terminated
HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - iNtellect Cranial Software, Part number 6000-650-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative su
Terminated
HAWK062640
Feb 23, 2011Integra LifeSciences Corp.
Integra Radionics HRAIM Intubation Head Ring Assembly Ref: HRAIM Head Rings serve as the general stereotactic treatment platform. Head Rings are used to provide a reference frame for instrumentation u
Terminated
HAWK944463
Feb 15, 2011Elekta, Inc.
Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data.
Terminated
HAWK972324
Feb 4, 2011Medtronic Navigation, Inc
Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Medtronic, Inc., Louisville, CO. Used in conjunction with the StealthSt
Terminated
HAWK050438
Dec 17, 2010Medtronic Navigation, Inc
Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 80027. Intended as an aid for precisely locating anatomical structures in either
Terminated
HAWK050438
Nov 3, 2010FHC, Inc.
Depth Stop Adapter 66-AC-DS(1.8), E6-01-.5 used with the microTargeting and STar Drives Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Driv
Terminated
HAWK003776
K092562
Nov 3, 2010FHC, Inc.
microTargeting Drive DBS Lead Holder 66-CN-DB Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commerciall
Terminated
HAWK003776
Nov 3, 2010FHC, Inc.
STar Drive System, Catalog numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be
Terminated
HAWK092562
Nov 3, 2010FHC, Inc.
microTargeting Drive System with Mounted Accessories Catalog numbers : 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic) Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and
Terminated
HAWK003776
Oct 26, 2010Medtronic Navigation, Inc
Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures. To be used with a Medtronic C
Terminated
HAWK050438
Jul 17, 2010Medtronic Navigation, Inc
Medtronic StealthStation S7 System
Terminated
HAWK050438
Apr 22, 2010Elekta, Inc.
Leksell SurgiPlan
Terminated
HAWK943468
Mar 3, 2010Medtronic Navigation, Inc
Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027. In combination with a tera-tracker reference frame, is used by an Orthopedic surgeon to navigate the loca
Terminated
HAWK021980
Dec 22, 2009Zimmer Inc.
Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects th
Terminated
HAWK060336
K071714 +1
Nov 20, 2009Stryker Instruments Div. of Stryker Corporation
Stryker Instruments Navigation System II PC SPC-1 Assembly, Stryker Navigation, Kalamazoo, MI; REF 7700-101-201. The Stryker Navigation System II is a computer-aided surgery platform, supporting surg
Terminated
HAWK993239
Nov 20, 2009Stryker Instruments Div. of Stryker Corporation
Stryker Instruments Navigation System II- CART, Stryker Navigation, Kalamazoo, MI; Stryker REF 7700-100-000. Intended to be used as a component of the Navigation System II.
Terminated
HAWK993239
Oct 19, 2009Mako Surgical Corporation
200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hybrid, UI Panel Subcomponents for the 203000 RIO STANDARD SYSTEM Manufactured
Terminated
HAWK081867
Mar 2, 2009Zimmer Inc.
Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument.
Terminated
HAWK071714
Feb 11, 2009Mako Surgical Corporation
Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002. Manufactured by: MAKO Surgical, Corp. The devices are accessories used with MAKO's Tactile Guidance System (TGS). The
Terminated
HAWK072806
Dec 22, 2008FHC, Inc.
FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). The device is a stereotactic instrument used for the placement of recordi
Terminated
HAWK011992
Sep 23, 2008Zimmer Inc.
Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc., Memphis, TN; ref: 111.100. Device is a surgical instrument.
Terminated
HAWK041369
Sep 20, 2008Zimmer Inc.
Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument.
Terminated
HAWK030827
Sep 16, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Ortholock, Stryker, Kalamazoo, MI; Part 6007-003-000. Stryker Ortholock is used to firmly anchor a tracker intended for patient tracking during computer aided orthopaedic and trauma applicati
Terminated
HAWK022365
K022579
Sep 16, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Ortholock EX Pin for use with the Stryker Navigation System, 4 mm x 150 mm, Stryker, Kalamazoo, MI; Part 6007-104-150. Stryker Navigation Pin for use with the Stryker Navigation System is us
Terminated
HAWK022365
K022579
Sep 16, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Ortholock EX Pin for use with the Stryker Navigation System, 3 mm x 110 mm, Stryker, Kalamazoo, MI; Part 6007-103-110. Stryker Navigation Pin for use with the Stryker Navigation System is use
Terminated
HAWK022365
K022579
Sep 16, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Navigation Pin for use with the Stryker Navigation System, 4 mm x 150 mm, Stryker, Kalamazoo, MI; Part 6007-004-150. Stryker Navigation Pin for use with the Stryker Navigation System is used
Terminated
HAWK022365
K022579
Sep 16, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Navigation Pin for use with the Stryker Navigation System, 4 mm x 100 mm, Stryker, Kalamazoo, MI; Part 6007-004-100. Stryker Navigation Pin for use with the Stryker Navigation System is used
Terminated
HAWK022365
K022579
Sep 16, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Navigation Pin for use with the Stryker Navigation System, 3 mm x 150 mm, Stryker, Kalamazoo, MI; Part 6007-003-150. Stryker Navigation Pin for use with the Stryker Navigation System is use
Terminated
HAWK022365
K022579
Sep 16, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Navigation Pin for use with the Stryker Navigation System, 3 mm x 100 mm, Stryker, Kalamazoo, MI; Part 6007-003-100. Stryker Navigation Pin for use with the Stryker navigation system is used
Terminated
HAWK022365
K022579
Jun 4, 2008Orthosoft, Inc. dba Zimmer CAS
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components
Terminated
HAWK071929
Feb 7, 2008Medtronic Image Guided Neurologics, Inc.
Nexframe Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041, DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST, DB-1043, DB-1043-BL, DB-1043-ST, DB-2
Terminated
HAWK012366
K022100 +2
Nov 8, 2006Plus Orthopedics USA
Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226
Terminated
HAWK020298
Oct 3, 2006Stryker Instruments Div. of Stryker Corporation
Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800, Stryker # 6000-200-000.
Terminated
HAWK004027
K993239
Oct 3, 2006Stryker Instruments Div. of Stryker Corporation
Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.
Terminated
HAWK004027
K993239
Oct 3, 2006Stryker Instruments Div. of Stryker Corporation
Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Terminated
HAWK004027
K993239
Oct 3, 2006Stryker Instruments Div. of Stryker Corporation
Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Terminated
HAWK004027
K993239
Apr 7, 2006Medtronic Navigation, Inc
AxiEM EM Knee Kit, and associated workstation.
Terminated
HAWK001284
K043088
Nov 23, 2005FHC, Inc.
Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66
Terminated
HAWK011992
Nov 23, 2005FHC, Inc.
FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS;66EL-MS-02; 66-EL-MS-03; 66-EL-RM; MT-DS-AM; MT-DS-MD.
Terminated
HAWK011992
Jun 16, 2005FHC, Inc.
FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)
Terminated
HAWK003776
K011775 +1
Apr 16, 2005Medtronic Surgical Navigation Technologies, Inc
Stealth Station Cranial Application v.4.5
Terminated
HAWK954276
Oct 19, 2004Stryker Instruments, Instruments Div.
Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000.
Terminated
HAWK022365

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