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

    DYNA-EXTOR II

    K Number: K110426 · Decision Nov 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    247
    Registration Numbers
    247
    Same Product Code
    392
    Applicant Total
    8
    Review Days
    261

    Basic Information

    Device Name
    DYNA-EXTOR II
    K Number
    K110426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BK MEDITECH CO., LTD.
    Date Received
    February 14, 2011
    Decision Date
    November 2, 2011
    Product Code
    KTT
    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
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KTT), ordered by most recent decision date.

    Extremity Medical External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Orthex External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Extremity Medical External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TrueLok Elevate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Monkey Bars Pin to Bar External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Response Ortho Metaphyseal Hinge Fixator System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by BK MEDITECH CO., LTD.

    K Number Device Name
    K140577 INNESIS PEEK TL CAGE
    K132483 INNESIS PEEK CERVICAL CAGE
    K120464 INNESIS PEEK CAGE
    K090424 DVX SPINE SYSTEM
    K080876 DVX SPINE SYSTEM
    K072436 MEGA SPINE SYSTEM
    K061599 PIN SCREW