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

    SKELITE RESORBABLE CEMENT RESTRICTOR

    K Number: K051836 · Decision Nov 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    53
    Applicant Total
    2
    Review Days
    138

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    Basic Information

    Device Name
    SKELITE RESORBABLE CEMENT RESTRICTOR
    K Number
    K051836
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Millenium Biologix, Inc.
    Date Received
    July 6, 2005
    Decision Date
    November 21, 2005
    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 Millenium Biologix, Inc.

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