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
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    11
    Review Days
    261

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    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.

    MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYNEX® External Fixation Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QuikFix External Fixator: Knee-Spanning Pack

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Excelsior System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hoffmann LRF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Monkey Rings External Ring Fixation System

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

    Other Clearances by Bk Meditech, Co., Ltd.

    K Number Device Name
    K200981 Mega Plus MIS Spine System
    K183080 Mega Plus Spine System
    K173180 Mega Plus Spine System
    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
    Search all 11 clearances from Bk Meditech, Co., Ltd. →