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

    BROOKER BIO-GROOVE FEMORAL COMPONENT

    K Number: K864085 · Decision Jan 28, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    106
    Applicant Total
    441
    Review Days
    100

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    Basic Information

    Device Name
    BROOKER BIO-GROOVE FEMORAL COMPONENT
    K Number
    K864085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Biomet, Inc.
    Date Received
    October 20, 1986
    Decision Date
    January 28, 1987
    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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