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

    X-STEN MILD TOOL KIT, MODEL MTK-0001

    K Number: K062038 · Decision Dec 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    368
    Registration Numbers
    368
    Same Product Code
    669
    Applicant Total
    2
    Review Days
    153

    Basic Information

    Device Name
    X-STEN MILD TOOL KIT, MODEL MTK-0001
    K Number
    K062038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    X-STEN CORP.
    Date Received
    July 19, 2006
    Decision Date
    December 19, 2006
    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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