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

    CoLink NeoFuse MIS Plating System (see attached parts list)

    K Number: K241387 · Decision Aug 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    CoLink NeoFuse MIS Plating System (see attached parts list)
    K Number
    K241387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    In2bones USA
    Date Received
    May 15, 2024
    Decision Date
    August 13, 2024
    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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