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510(k) Data Aggregation

    K Number
    K062146
    Device Name
    UNI KNEE SURGETICS NAVIGATION SYSTEM
    Manufacturer
    PRAXIM S.A
    Date Cleared
    2006-08-21

    (25 days)

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

    PRAXIM S.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNI KNEE SURGETICS Navigation System 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 : - UniKnee Arthroplasty .
    Device Description
    As the equivalent Surgetics ORTHO KNEELOGICS Navigation System and TOTAL KNEE SURGETICS Navigation System, the UNI KNEE SURGETICS 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 - UNI KNEE SURGETICS software . The main modifications to the predicate devices concern the internal architecture of the software, allowing more easily to integrate new implants and to better adapt the workflow to different surgical techniques. New instruments adapted to new implants are also incorporated.
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