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

    LINK CEMENTLESS SCREW-IN ACETABULAR CUP

    K Number: K843950 · Decision Jun 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    113
    Applicant Total
    42
    Review Days
    237

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    Basic Information

    Device Name
    LINK CEMENTLESS SCREW-IN ACETABULAR CUP
    K Number
    K843950
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    888.3330
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Waldemar Link GmbH & Co. KG
    Date Received
    October 9, 1984
    Decision Date
    June 3, 1985
    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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