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

    ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)

    K Number: K885069 · Decision Sep 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    71
    Review Days
    267

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    Basic Information

    Device Name
    ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
    K Number
    K885069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Richards Medical Co., Inc.
    Date Received
    December 8, 1988
    Decision Date
    September 1, 1989
    Product Code
    LZO
    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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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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
    K892366 POROUS GENESIS STEMMED TIBIAL COMPONENT
    K890132 POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.
    Search all 71 clearances from Richards Medical Co., Inc. →