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

    UNIVERSAL SELF-ALIGNING ACETABULAR COM

    K Number: K834035 · Decision Jun 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    45
    Review Days
    209

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    Basic Information

    Device Name
    UNIVERSAL SELF-ALIGNING ACETABULAR COM
    K Number
    K834035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Orthopedic Equipment Co., Inc.
    Date Received
    November 23, 1983
    Decision Date
    June 19, 1984
    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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