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

    TriMed® Compression Screws

    K Number: K243943 · Decision Apr 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    653
    Registration Numbers
    653
    Same Product Code
    1040
    Applicant Total
    19
    Review Days
    111

    Basic Information

    Device Name
    TriMed® Compression Screws
    K Number
    K243943
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TriMed, Inc.
    Date Received
    December 20, 2024
    Decision Date
    April 10, 2025
    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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