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

    PROSTHETIC CEMENT REMOVER

    K Number: K890285 · Decision Apr 19, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    PROSTHETIC CEMENT REMOVER
    K Number
    K890285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.4580
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Albert K. Chin
    Date Received
    January 19, 1989
    Decision Date
    April 19, 1989
    Product Code
    LZV
    Advisory Committee
    Orthopedic
    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
    LZV System, Cement Removal Extraction

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