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

    Epic Extremity Plate System

    K Number: K153340 · Decision Feb 9, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    5
    Review Days
    82

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    Basic Information

    Device Name
    Epic Extremity Plate System
    K Number
    K153340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epic Extremity, LLC
    Date Received
    November 19, 2015
    Decision Date
    February 9, 2016
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Epic Extremity, LLC

    K Number Device Name
    K182991 EPIC Extremity Fusion Plate System
    K172441 EPIC Extremity Fracture Plate System
    K163038 EPIC Extremity Snap-Off Screw
    K153333 Epic Extremity Cannulated Screw System