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

    KAMPNER HINGED TOE PROSTHESIS

    K Number: K801345 · Decision Jul 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    20
    Applicant Total
    10
    Review Days
    32

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    Basic Information

    Device Name
    KAMPNER HINGED TOE PROSTHESIS
    K Number
    K801345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3720
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Biomedics
    Date Received
    June 6, 1980
    Decision Date
    July 8, 1980
    Product Code
    KWH
    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
    KWH Prosthesis, Toe, Constrained, Polymer

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