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

    P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL

    K Number: K914439 · Decision Oct 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    113
    Applicant Total
    22
    Review Days
    19

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    Basic Information

    Device Name
    P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL
    K Number
    K914439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Orthopaedics, Inc.
    Date Received
    October 4, 1991
    Decision Date
    October 23, 1991
    Product Code
    HSX
    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
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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    Other Clearances by Johnson & Johnson Orthopaedics, Inc.

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    K940190 ULTIMA UNIPOLAR MODULAR HEAD
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    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
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