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

    Epic Extremity Cannulated Screw System

    K Number: K153333 · Decision Jan 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    653
    Registration Numbers
    653
    Same Product Code
    1040
    Applicant Total
    2
    Review Days
    61

    Basic Information

    Device Name
    Epic Extremity Cannulated Screw System
    K Number
    K153333
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epic Extremity, LLC
    Date Received
    November 19, 2015
    Decision Date
    January 19, 2016
    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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    Other Clearances by Epic Extremity, LLC

    K Number Device Name
    K153340 Epic Extremity Plate System