BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    arcad® 2.0 Duo & Quadro osteosynthesis compressive staples

    K Number: K230724 · Decision Dec 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    8
    Review Days
    263

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    Basic Information

    Device Name
    arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
    K Number
    K230724
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novastep
    Date Received
    March 16, 2023
    Decision Date
    December 4, 2023
    Product Code
    JDR
    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
    JDR Staple, Fixation, Bone

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    Other Clearances by Novastep

    K Number Device Name
    K223468 Nexis® compressive screws
    K192356 Airlock Centrolock Osteosynthesis Implant System
    K151277 Airlock® osteosynthesis plate system
    K143523 Airlock osteosynthesis plate system
    K143049 LYNC intramedullary implant
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    K143146 Nexis osteosynthesis snap-off screws