BEUDAMED
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    S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    UPGRD PRGM 9734638 ADD AxiEM NAVIGATION

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014

    StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 21, 2013

    Medtronic Navigation O-arm 02 surgical x-ray imaging system

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.-Littleton·July 13, 2016

    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 location of an acetabular cup positioner/impactor during hip replacement surgery.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc·Product code HAW·November 3, 2009

    Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable handheld 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.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·February 6, 2012

    The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·December 5, 2012

    Left Long Tactile Probe, 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.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·February 6, 2012

    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.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc·Product code HAW·January 20, 2011

    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.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc·Product code HAW·January 20, 2011

    Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0)

    FDA Recall
    Terminated ·Medtronic Navigation, Inc·Product code JZL·October 17, 2007

    Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc·Product code HAW·December 22, 2010

    Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surgery.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·July 8, 2015

    Medtronic Navigation O-arm 02 surgical x-ray imaging system

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.-Littleton·Product code OWB·March 17, 2016