BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    LORRAINE 2.5/3.5mm Distal Humerus System

    K Number: K250933 · Decision Jun 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    505
    Registration Numbers
    505
    Same Product Code
    1254
    Applicant Total
    7
    Review Days
    75

    Basic Information

    Device Name
    LORRAINE 2.5/3.5mm Distal Humerus System
    K Number
    K250933
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bonebridge AG
    Date Received
    March 28, 2025
    Decision Date
    June 11, 2025
    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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    K Number Device Name
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