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510(k) Data Aggregation

    K Number
    K123795
    Device Name
    AXON-BUS PROSTHETIC SYSTEM
    Manufacturer
    OTTO BOCK AUSTRIA
    Date Cleared
    2014-06-03

    (540 days)

    Product Code
    GXY, IQZ
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTTO BOCK AUSTRIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axon-Bus Prosthetic System is to be used exclusively for exoprosthetic fittings of the upper limbs.
    Device Description
    The Axon-Bus Prosthetic System is to be used exclusively for upper limb exoprosthetic fitting. The Axon-Bus Prosthetic System is suitable for unilateral amputations starting with the transradial/transhumeral amputation level or, in case of dysmelia, for forearm or upper arm fittings. The Axon-Bus prosthetic system was developed for everyday use and must not be used for unusual activities. The prosthesis is intended exclusively for use on one patient. Fitting a patient with the Axon-Bus prosthetic system may only be carried out by a prosthetist who has been authorized by Ottobock after completion of a corresponding training course. System Components: - Michelangelo Hand (terminal device) - AxonFlexion Adapter (passive flexion) - AxonRotation Adapter (passive rotation) - AxonArm (passive elbow joint with mechanical and/or electrical lock) - AxonEnergy Integral (battery) - AxonCharge (charger) - AxonMaster (control unit) - Electrode (detecting EMG Input signals) - AxonSoft (adjustment software) - AxonSkin (prosthetic glove)
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