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

    KM-5 METAL BACKED ACETABULAR CUP

    K Number: K902279 · Decision Aug 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    76
    Review Days
    79

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    Basic Information

    Device Name
    KM-5 METAL BACKED ACETABULAR CUP
    K Number
    K902279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Kirschner Medical Corp.
    Date Received
    May 22, 1990
    Decision Date
    August 9, 1990
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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