BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE

    K Number: K905451 · Decision Mar 5, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    37
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE
    K Number
    K905451
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.4580
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Advanced Osseous Technologies
    Date Received
    December 5, 1990
    Decision Date
    March 5, 1991
    Product Code
    JDX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JDX Instrument, Surgical, Sonic And Accessory/Attachment

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    Other Clearances by Advanced Osseous Technologies

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