BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    G21 Cement, VADER® Pedicle System

    K Number: K200596 · Decision Oct 13, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    18
    Applicant Total
    16
    Review Days
    221

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    Basic Information

    Device Name
    G21 Cement, VADER® Pedicle System
    K Number
    K200596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Icotec AG
    Date Received
    March 6, 2020
    Decision Date
    October 13, 2020
    Product Code
    PML
    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
    PML Bone Cement, Posterior Screw Augmentation

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    Other Clearances by Icotec AG

    K Number Device Name
    K252327 CMORE® CT System; CMORE® CT System Navigated Instruments
    K242900 VADER® Pedicle System and VADER®one Pedicle System
    K233215 icotec Anterior Cervical Plate System
    K232792 icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)
    K232790 KONG®-TL VBR System and KONG® C VBR System
    K232628 VADER® Pedicle System
    K230861 VADER® Pedicle System Navigated Instruments
    K222789 VADER® Pedicle System, G21 Cement
    K201587 icotec Anterior Cervical Plate System
    K200235 KONG-TL VBR System, KONG-C VBR System
    Search all 16 clearances from Icotec AG →