BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38

    K Number: K070221 · Decision Apr 4, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    113
    Applicant Total
    52
    Review Days
    70

    Basic Information

    Device Name
    FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
    K Number
    K070221
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    888.3330
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ENCORE MEDICAL, L.P.
    Date Received
    January 24, 2007
    Decision Date
    April 4, 2007
    Product Code
    KWA
    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
    KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

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