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

    DIMENSION REVISION TOTAL HIP SYSTEM

    K Number: K895636 · Decision Dec 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Same Product Code
    560
    Applicant Total
    76
    Review Days
    86

    Basic Information

    Device Name
    DIMENSION REVISION TOTAL HIP SYSTEM
    K Number
    K895636
    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
    September 19, 1989
    Decision Date
    December 14, 1989
    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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