BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    REL-K ARTIFICAL LIMB PROSTHESIS

    K Number: K101859 · Decision Oct 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    103

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    Basic Information

    Device Name
    REL-K ARTIFICAL LIMB PROSTHESIS
    K Number
    K101859
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3420
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rizzoli Ortopedica S.P.A.
    Date Received
    July 2, 2010
    Decision Date
    October 13, 2010
    Product Code
    ISY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ISY Joint, Knee, External Limb Component