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

    ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM

    K Number: K924379 · Decision Feb 12, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    106
    Applicant Total
    22
    Review Days
    165

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    Basic Information

    Device Name
    ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM
    K Number
    K924379
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Orthopaedics, Inc.
    Date Received
    August 31, 1992
    Decision Date
    February 12, 1993
    Product Code
    KWL
    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
    KWL Prosthesis, Hip, Hemi-, Femoral, Metal

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    Other Clearances by Johnson & Johnson Orthopaedics, Inc.

    K Number Device Name
    K931466 PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI
    K935452 P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
    K940190 ULTIMA UNIPOLAR MODULAR HEAD
    K933275 P.F.C. CERAMIC HIP HEAD
    K932595 ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR
    K931655 P.F.C. BIPOLAR HIP SYSTEM
    K933867 UNIVERSAL INSET PATELLA
    K935262 P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA
    K931189 P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET
    K931054 TRICK MODULAR KNEE TIBIAL TRAY-POROUS
    Search all 22 clearances from Johnson & Johnson Orthopaedics, Inc. →