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

    FLEXIBLE INTRAMEDULLARY REAMER

    K Number: K954915 · Decision Dec 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    354
    Registration Numbers
    354
    Same Product Code
    13
    Applicant Total
    376
    Review Days
    63

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    Basic Information

    Device Name
    FLEXIBLE INTRAMEDULLARY REAMER
    K Number
    K954915
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer, Inc.
    Date Received
    October 26, 1995
    Decision Date
    December 28, 1995
    Product Code
    HTO
    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
    HTO Reamer

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