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

    Medline UNITE IM Fibula Implant

    K Number: K220511 · Decision Mar 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    29
    Review Days
    28

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    Basic Information

    Device Name
    Medline UNITE IM Fibula Implant
    K Number
    K220511
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medline Industries, LP
    Date Received
    February 22, 2022
    Decision Date
    March 22, 2022
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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