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

    X12 STERILE REFLECTIVE MARKER SPHERE

    K Number: K111443 · Decision Sep 29, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    2
    Review Days
    128

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    Basic Information

    Device Name
    X12 STERILE REFLECTIVE MARKER SPHERE
    K Number
    K111443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pinsco Inc. Dba B & L Engineering
    Date Received
    May 24, 2011
    Decision Date
    September 29, 2011
    Product Code
    OLO
    Advisory Committee
    Neurology
    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
    OLO Orthopedic Stereotaxic Instrument

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