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

    BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System

    K Number: K252191 · Decision Dec 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    9
    Review Days
    156

    Basic Information

    Device Name
    BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
    K Number
    K252191
    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
    July 14, 2025
    Decision Date
    December 17, 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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    Other Clearances by Bonebridge AG

    K Number Device Name
    K260228 POYA 3.5mm Medial Proximal Tibia System
    K250933 LORRAINE 2.5/3.5mm Distal Humerus System
    K243308 Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
    K242399 Bonebridge Osteosynthesis Plating System
    K240318 SITTER 3.5mm Versatile System
    K231292 TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System
    K213864 Bonebridge Osteosynthesis Plating System
    K203002 SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System