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

    THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS

    K Number: K132049 · Decision Aug 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    4
    Review Days
    409

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    Basic Information

    Device Name
    THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS
    K Number
    K132049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Choicespine
    Date Received
    July 2, 2013
    Decision Date
    August 15, 2014
    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 Choicespine

    K Number Device Name
    K183588 Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
    K171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
    K171456 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems