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

    KM-4(TM) METAL-BACKED ACETABULAR CUP

    K Number: K870867 · Decision May 8, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    44
    Applicant Total
    76
    Review Days
    66

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    Basic Information

    Device Name
    KM-4(TM) METAL-BACKED ACETABULAR CUP
    K Number
    K870867
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    888.3320
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Kirschner Medical Corp.
    Date Received
    March 3, 1987
    Decision Date
    May 8, 1987
    Product Code
    JDL
    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
    JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

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