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

    K'FIX

    K Number: K010847 · Decision Jun 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    1
    Applicant Total
    18
    Review Days
    90

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    Basic Information

    Device Name
    K'FIX
    K Number
    K010847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avanta Orthopaedics, Inc.
    Date Received
    March 21, 2001
    Decision Date
    June 19, 2001
    Product Code
    NDL
    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
    NDL Pin, Fixation, Smooth, Metallic

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    TBW

    FDA 510(k)
    FDA Class 2 ·Orthopedic
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