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

    XT3 System

    K Number: K241357 · Decision Jan 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    93
    Applicant Total
    2
    Review Days
    253

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    Basic Information

    Device Name
    XT3 System
    K Number
    K241357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biodynamik, Inc.
    Date Received
    May 14, 2024
    Decision Date
    January 22, 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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    Other Clearances by Biodynamik, Inc.

    K Number Device Name
    K260073 XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm