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

    PROXIMAL CEMENT SPACER

    K Number: K895378 · Decision Nov 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    53
    Applicant Total
    2
    Review Days
    84

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    Basic Information

    Device Name
    PROXIMAL CEMENT SPACER
    K Number
    K895378
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Osteonics Reconstructive Products Div.
    Date Received
    August 30, 1989
    Decision Date
    November 22, 1989
    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 Osteonics Reconstructive Products Div.

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