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

    TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER

    K Number: K946313 · Decision Mar 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    15
    Review Days
    79

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    Basic Information

    Device Name
    TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER
    K Number
    K946313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith and Nephew Donjoy, Inc.
    Date Received
    December 28, 1994
    Decision Date
    March 17, 1995
    Product Code
    HRX
    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
    HRX Arthroscope

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