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

    ENDER PINS

    K Number: K811002 · Decision Apr 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    48
    Review Days
    16

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    Basic Information

    Device Name
    ENDER PINS
    K Number
    K811002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Richard'S Medical Equip., Inc.
    Date Received
    April 13, 1981
    Decision Date
    April 29, 1981
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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    K823723 SPECTRON PROXIMAL FEMORAL PROSTHESIS
    K823722 SPECTRON LONG, STRAIGHT FEMORAL PROSTHES
    K823727 SPECTRON PRIMARY STEM FEMORAL PROSTHES
    K830153 RICHARDS INTRA-ARTICULAR SHAVER BLADES
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