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

    IMPLANT, H.P. CONDYLAR

    K Number: K781870 · Decision Feb 9, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    31
    Review Days
    98

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    Basic Information

    Device Name
    IMPLANT, H.P. CONDYLAR
    K Number
    K781870
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3730
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    November 3, 1978
    Decision Date
    February 9, 1979
    Product Code
    KWD
    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
    KWD Prosthesis, Toe, Hemi-, Phalangeal

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