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

    BIO-FIT HIP SYSTEM

    K Number: K854791 · Decision Feb 27, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    106
    Applicant Total
    71
    Review Days
    90

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    Basic Information

    Device Name
    BIO-FIT HIP SYSTEM
    K Number
    K854791
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Richards Medical Co., Inc.
    Date Received
    November 29, 1985
    Decision Date
    February 27, 1986
    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 Richards Medical Co., Inc.

    K Number Device Name
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    K895242 PAPPAS TRI-FLANGE VENTILATION TUBE
    K893377 RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
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