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

    NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS

    K Number: K002356 · Decision Oct 30, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    26
    Applicant Total
    45
    Review Days
    89

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    Basic Information

    Device Name
    NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS
    K Number
    K002356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sulzer Orthopedics, Inc.
    Date Received
    August 2, 2000
    Decision Date
    October 30, 2000
    Product Code
    KRR
    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
    KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

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    Other Clearances by Sulzer Orthopedics, Inc.

    K Number Device Name
    K022985 ASCENDENT ACETABULAR SYSTEM
    K021578 NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
    K020713 MS-30 LATERAL FEMORAL STEM
    K013935 ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
    K013031 MOST OPTIONS SYSTEM
    K012739 CONVERGE ACETABULAR SYSTEM
    K012961 SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
    K011954 SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
    K010839 CLS VARUS STEM/CLS 135 STEM
    K003758 ALLOFIT ACETABULAR SYSTEM
    Search all 45 clearances from Sulzer Orthopedics, Inc. →