BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    OSSIOfiber® Cannulated Trimmable Fixation Nail

    K Number: K230750 · Decision Sep 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    200
    Applicant Total
    7
    Review Days
    180

    Basic Information

    Device Name
    OSSIOfiber® Cannulated Trimmable Fixation Nail
    K Number
    K230750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ossio Ltd.
    Date Received
    March 17, 2023
    Decision Date
    September 13, 2023
    Product Code
    HTY
    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
    HTY Pin, Fixation, Smooth

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