LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K090953
    Device Name
    TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
    Manufacturer
    PRAXIM MEDIVISION, SA
    Date Cleared
    2010-01-21

    (293 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRAXIM MEDIVISION, SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty
    Device Description
    As the equivalent TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK consists of the following major components and subsystems: - The Station (Surgetics or NanoStation), consisting of a mobile computer system and an optical localizer - . Ancillary instruments, a specific motorized cutting block and reflective markers used for reference and registration - TOTAL KNEE SURGETICS software application with iBlock option . The main modification to the predicate device K081232 concerns the modification of the motorized cutting block PRAXITELES®.
    Ask a Question
    K Number
    K063408
    Device Name
    CTLOGICS NAVIGATIONS SYSTEMS
    Manufacturer
    PRAXIM MEDIVISION, SA
    Date Cleared
    2007-02-28

    (107 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRAXIM MEDIVISION, SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTLOGICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures. The system which uses patient's preoperative image data is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone, or a vertebra can be identified relative to CT-based model of the anatomical structure. Example procedures include but are not limited to: Posterior spinal implant procedures such as pedicle screw placement, kyphoplasty and vertebroplasty procedures, thoracic spine surgery, tumor surgery on the spinal column. Superolateral and deltopectoral shoulder procedures, such as guiding the glenoid component on the scapula.
    Device Description
    The CTLOGICS Navigation System consists of the following major components and subsystems: - The Surgetics Station or the NanoStation, consisting of a mobile computer . system and an optical localizer - Ancillary instruments and reflective markers used for reference and . registration - . CTLOGICS Software
    Ask a Question

    Page 1 of 1