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

    SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)

    K Number: K113362 · Decision Feb 10, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    368
    Registration Numbers
    368
    Same Product Code
    669
    Applicant Total
    8
    Review Days
    87

    Basic Information

    Device Name
    SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
    K Number
    K113362
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SPINE VIEW, INC.
    Date Received
    November 15, 2011
    Decision Date
    February 10, 2012
    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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