BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent for Some Indications 🇺🇸 United States

    KOENIG TOTAL TOE IMPLANT

    K Number: K884561 · Decision Jan 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    10
    Applicant Total
    74
    Review Days
    85

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    Basic Information

    Device Name
    KOENIG TOTAL TOE IMPLANT
    K Number
    K884561
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Dow Corning Wright
    Date Received
    October 31, 1988
    Decision Date
    January 24, 1989
    Product Code
    LZJ
    Advisory Committee
    Unknown
    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
    LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

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