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

    OSTEONICS UNIVERSAL DISTAL CEMENT PLUG

    K Number: K992462 · Decision Aug 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    36
    Applicant Total
    288
    Review Days
    21

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    Basic Information

    Device Name
    OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
    K Number
    K992462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp.
    Date Received
    July 23, 1999
    Decision Date
    August 13, 1999
    Product Code
    LZN
    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
    LZN Cement Obturator

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