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

    THEKEN SMALL CEMENT RESTRICTOR

    K Number: K012278 · Decision Oct 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    53
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    THEKEN SMALL CEMENT RESTRICTOR
    K Number
    K012278
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Theken Surgical,Llc
    Date Received
    July 19, 2001
    Decision Date
    October 17, 2001
    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 Theken Surgical,Llc

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