BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    KRONNER SPHERICAL CUTTERS

    K Number: K894228 · Decision Jul 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    434
    Registration Numbers
    434
    Same Product Code
    9
    Applicant Total
    7
    Review Days
    399

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    Basic Information

    Device Name
    KRONNER SPHERICAL CUTTERS
    K Number
    K894228
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4800
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Kronner Medical
    Date Received
    June 19, 1989
    Decision Date
    July 23, 1990
    Product Code
    HWT
    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
    HWT Template

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