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

    INCUS PROSTHESIS

    K Number: K844961 · Decision Feb 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    71
    Applicant Total
    71
    Review Days
    67

    Basic Information

    Device Name
    INCUS PROSTHESIS
    K Number
    K844961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    RICHARDS MEDICAL CO., INC.
    Date Received
    December 21, 1984
    Decision Date
    February 26, 1985
    Product Code
    ETB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETB Prosthesis, Partial Ossicular Replacement

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    Other Clearances by RICHARDS MEDICAL CO., INC.

    K Number Device Name
    K896106 ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS
    K900628 MODULAR HIP SYSTEM
    K896580 UNI-POLAR HEAD
    K895241 INTRAMEDULLARY HIP SCREW
    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)
    K890132 POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.
    Search all 71 clearances from RICHARDS MEDICAL CO., INC. →