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510(k) Data Aggregation

    K Number
    K013429
    Device Name
    ACTAEON PROBE
    Manufacturer
    OSTEOBIOLOGICS, INC.
    Date Cleared
    2002-01-11

    (87 days)

    Product Code
    NGR
    Regulation Number
    888.1100
    Why did this record match?
    Product Code :

    NGR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACTAEON™ Probe arthroscopic cartilage stiffness tester is indicated for an arthroscopic in vivo point measurement of articular cartilage stiffness in humans. The ACTAEON™ Probe can be used arthroscopically or in open joint procedures.
    Device Description
    The ACTAEON™ Probe is a hand-held device which when activated by the user measures the reaction force (resistance) of articular cartilage against a known rate and force of indentation applied by the disposable indenting tip of the device.
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    K Number
    K010303
    Device Name
    ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
    Manufacturer
    ARTSCAN MEDICAL INNOVATIONS
    Date Cleared
    2001-09-11

    (280 days)

    Product Code
    NGR
    Regulation Number
    888.1100
    Why did this record match?
    Product Code :

    NGR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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