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

    CONSENSUS(TM) TOTAL HIP SYSTEM

    K Number: K922561 · Decision Jul 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    44
    Applicant Total
    24
    Review Days
    413

    Basic Information

    Device Name
    CONSENSUS(TM) TOTAL HIP SYSTEM
    K Number
    K922561
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    888.3320
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    U.S. MEDICAL PRODUCTS, INC.
    Date Received
    June 3, 1992
    Decision Date
    July 21, 1993
    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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