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

    SYNTHES MIRS

    K Number: K113044 · Decision Dec 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    36
    Review Days
    70

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    Basic Information

    Device Name
    SYNTHES MIRS
    K Number
    K113044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes Spine
    Date Received
    October 12, 2011
    Decision Date
    December 21, 2011
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    Other Clearances by Synthes Spine

    K Number Device Name
    K122211 SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
    K120838 SYNTHES MATRIX SYSTEM
    K111048 SYNTHES SCOUT TACK FIXATION
    K120928 SYNTHES MATRIX SYSTEM
    K120571 SYNTHES USS CONNECTOR
    K113149 SYNTHES USS CONNECTORS
    K111358 SYNTHES USS
    K103558 SYNTHES SCOUT VESSEL GUARD
    K103287 SYNTHES 6.0 COCR AND CPT TI-3 RODS
    K093762 SYNTHES ZERO-P
    Search all 36 clearances from Synthes Spine →