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)
Top companies in HAW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2011 | Stryker 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 |
HAW | K062640 |
| Feb 25, 2011 | Stryker 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 |
HAW | K062640 |
| Feb 25, 2011 | Stryker 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 |
HAW | K062640 |
| Feb 25, 2011 | Stryker 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 |
HAW | K062640 |
| Feb 25, 2011 | Stryker 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 |
HAW | K062640 |
| Feb 25, 2011 | Stryker 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 |
HAW | K062640 |
| Feb 25, 2011 | Stryker 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 |
HAW | K062640 |
| Feb 25, 2011 | Stryker 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 |
HAW | K062640 |
| Feb 25, 2011 | Stryker 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 |
HAW | K062640 |
| Feb 23, 2011 | Integra 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 |
HAW | K944463 |
| Feb 15, 2011 | Elekta, Inc. Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data. Terminated |
HAW | K972324 |
| Feb 4, 2011 | Medtronic 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 |
HAW | K050438 |
| Dec 17, 2010 | Medtronic 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 |
HAW | K050438 |
| Nov 3, 2010 | FHC, 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 |
HAW | K003776 K092562 |
| Nov 3, 2010 | FHC, 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 |
HAW | K003776 |
| Nov 3, 2010 | FHC, 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 |
HAW | K092562 |
| Nov 3, 2010 | FHC, 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 |
HAW | K003776 |
| Oct 26, 2010 | Medtronic 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 |
HAW | K050438 |
| Jul 17, 2010 | Medtronic Navigation, Inc Medtronic StealthStation S7 System Terminated |
HAW | K050438 |
| Apr 22, 2010 | Elekta, Inc. Leksell SurgiPlan Terminated |
HAW | K943468 |
| Mar 3, 2010 | Medtronic 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 |
HAW | K021980 |
| Dec 22, 2009 | Zimmer 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 |
HAW | K060336 K071714 +1 |
| Nov 20, 2009 | Stryker 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 |
HAW | K993239 |
| Nov 20, 2009 | Stryker 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 |
HAW | K993239 |
| Oct 19, 2009 | Mako 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 |
HAW | K081867 |
| Mar 2, 2009 | Zimmer Inc. Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument. Terminated |
HAW | K071714 |
| Feb 11, 2009 | Mako 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 |
HAW | K072806 |
| Dec 22, 2008 | FHC, 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 |
HAW | K011992 |
| Sep 23, 2008 | Zimmer 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 |
HAW | K041369 |
| Sep 20, 2008 | Zimmer Inc. Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument. Terminated |
HAW | K030827 |
| Sep 16, 2008 | Stryker 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 |
HAW | K022365 K022579 |
| Sep 16, 2008 | Stryker 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 |
HAW | K022365 K022579 |
| Sep 16, 2008 | Stryker 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 |
HAW | K022365 K022579 |
| Sep 16, 2008 | Stryker 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 |
HAW | K022365 K022579 |
| Sep 16, 2008 | Stryker 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 |
HAW | K022365 K022579 |
| Sep 16, 2008 | Stryker 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 |
HAW | K022365 K022579 |
| Sep 16, 2008 | Stryker 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 |
HAW | K022365 K022579 |
| Jun 4, 2008 | Orthosoft, 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 |
HAW | K071929 |
| Feb 7, 2008 | Medtronic 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 |
HAW | K012366 K022100 +2 |
| Nov 8, 2006 | Plus Orthopedics USA Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226 Terminated |
HAW | K020298 |
| Oct 3, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800, Stryker # 6000-200-000. Terminated |
HAW | K004027 K993239 |
| Oct 3, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064. Terminated |
HAW | K004027 K993239 |
| Oct 3, 2006 | Stryker 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 |
HAW | K004027 K993239 |
| Oct 3, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000. Terminated |
HAW | K004027 K993239 |
| Apr 7, 2006 | Medtronic Navigation, Inc AxiEM EM Knee Kit, and associated workstation. Terminated |
HAW | K001284 K043088 |
| Nov 23, 2005 | FHC, Inc. Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66 Terminated |
HAW | K011992 |
| Nov 23, 2005 | FHC, 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 |
HAW | K011992 |
| Jun 16, 2005 | FHC, 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 |
HAW | K003776 K011775 +1 |
| Apr 16, 2005 | Medtronic Surgical Navigation Technologies, Inc Stealth Station Cranial Application v.4.5 Terminated |
HAW | K954276 |
| Oct 19, 2004 | Stryker Instruments, Instruments Div. Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000. Terminated |
HAW | K022365 |
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