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

    OsteoMed ExtremiFix Mini & Small System Tray

    K Number: K202105 · Decision Oct 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    5
    Review Days
    92

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    Basic Information

    Device Name
    OsteoMed ExtremiFix Mini & Small System Tray
    K Number
    K202105
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteomed, LLC
    Date Received
    July 29, 2020
    Decision Date
    October 29, 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 Osteomed, LLC

    K Number Device Name
    K212570 OsteoPlan System
    K202680 OsteoMed ExtremiFix Mini & Small Cannulated Screw System
    K173391 OsteoMed QuickFix Hybrid MMF Sterilization Tray
    K163303 OsteoMed ExtremiFix Mid and Large Screw System