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

    CEMENT RESTRICTOR

    K Number: K840413 · Decision Mar 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    53
    Applicant Total
    6
    Review Days
    34

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    Basic Information

    Device Name
    CEMENT RESTRICTOR
    K Number
    K840413
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Ortomed Corp.
    Date Received
    January 31, 1984
    Decision Date
    March 5, 1984
    Product Code
    JDK
    Advisory Committee
    General, Plastic Surgery
    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
    JDK Prosthesis, Hip, Cement Restrictor

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    Other Clearances by American Ortomed Corp.

    K Number Device Name
    K842518 UNILOC-CEMENTLESS & SELF TAP ACETABULAR
    K842466 TITANIUM MITTELMEIER TYPE ACETABULAR
    K842465 UNILOC
    K820719 THE ICR KNEE
    K780497 SPHERISTEM TOTAL HIP PROSTHESIS