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

    Airlock® osteosynthesis plate system

    K Number: K151277 · Decision Aug 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    8
    Review Days
    91

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    Basic Information

    Device Name
    Airlock® osteosynthesis plate system
    K Number
    K151277
    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
    May 14, 2015
    Decision Date
    August 13, 2015
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Novastep

    K Number Device Name
    K230724 arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
    K223468 Nexis® compressive screws
    K192356 Airlock Centrolock Osteosynthesis Implant System
    K143523 Airlock osteosynthesis plate system
    K143049 LYNC intramedullary implant
    K143229 Nexis osteosynthesis compressive screws
    K143146 Nexis osteosynthesis snap-off screws