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

    Meduloc Intramedullary Fracture Fixation (IFF) System

    K Number: K250316 · Decision Oct 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    93
    Applicant Total
    1
    Review Days
    267

    Basic Information

    Device Name
    Meduloc Intramedullary Fracture Fixation (IFF) System
    K Number
    K250316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meduloc, LLC
    Date Received
    February 4, 2025
    Decision Date
    October 29, 2025
    Product Code
    JDW
    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
    JDW Pin, Fixation, Threaded

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