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

    EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device

    K Number: K202270 · Decision Dec 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    4
    Review Days
    113

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    Basic Information

    Device Name
    EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
    K Number
    K202270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    K1 Medical, LLC
    Date Received
    August 11, 2020
    Decision Date
    December 2, 2020
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by K1 Medical, LLC

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