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

    M.U.S.T. EXTENSION

    K Number: K141044 · Decision Aug 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    39
    Review Days
    117

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    Basic Information

    Device Name
    M.U.S.T. EXTENSION
    K Number
    K141044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medacta International
    Date Received
    April 23, 2014
    Decision Date
    August 18, 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 Medacta International

    K Number Device Name
    K160605 MectaLIF Anterior Stand-Alone
    K160289 MasterLoc Stem
    K153664 M.U.S.T. Pedicle Screw System
    K151531 MasterLoc Stem
    K142744 Mecta-C TiPEEK
    K143453 Mpact Double Mobility System
    K142069 GMK EXTENSION
    K141988 M.U.S.T PEDICLE SCREW SYSTEM
    K140826 GMK SPHERE EXTENSION
    K140361 META-C CERVICAL PLATE
    Search all 39 clearances from Medacta International →