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

    SWANSON TITANIUM CARPAL SCAPHOID IMPLANT

    K Number: K864490 · Decision Apr 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    0
    Applicant Total
    74
    Review Days
    153

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    Basic Information

    Device Name
    SWANSON TITANIUM CARPAL SCAPHOID IMPLANT
    K Number
    K864490
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3760
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Wright
    Date Received
    November 13, 1986
    Decision Date
    April 15, 1987
    Product Code
    KWO
    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
    KWO Prosthesis, Wrist, Carpal Scaphoid

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