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

    TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)

    K Number: K251945 · Decision Jul 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    505
    Registration Numbers
    505
    Same Product Code
    1254
    Applicant Total
    19
    Review Days
    15

    Basic Information

    Device Name
    TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
    K Number
    K251945
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TriMed, Inc.
    Date Received
    June 25, 2025
    Decision Date
    July 10, 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 TriMed, Inc.

    K Number Device Name
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    K243999 TriMed Ankle Fixation System
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    K241942 TriMed Bridge Plates
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