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

    CANAL WALL PROSTHESIS

    K Number: K844960 · Decision Feb 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    71
    Review Days
    67

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    Basic Information

    Device Name
    CANAL WALL PROSTHESIS
    K Number
    K844960
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3590
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Richards Medical Co., Inc.
    Date Received
    December 21, 1984
    Decision Date
    February 26, 1985
    Product Code
    FZD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FZD Prosthesis, Ear, Internal

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    K884824 TRICON-M TOTAL KNEE SYSTEM
    K896204 ZIRCONIA CERAMIC HEAD ADD'L SIZES
    K895242 PAPPAS TRI-FLANGE VENTILATION TUBE
    K893377 RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
    K885069 ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
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