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

    PRECICE Trauma Nail System

    K Number: K160267 · Decision Mar 31, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    7
    Review Days
    58

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    Basic Information

    Device Name
    PRECICE Trauma Nail System
    K Number
    K160267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ellipse Technologies, Incorporated
    Date Received
    February 2, 2016
    Decision Date
    March 31, 2016
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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    Other Clearances by Ellipse Technologies, Incorporated

    K Number Device Name
    K151594 Ellipse Supplemental Instrument Trays
    K152370 PRECICE Trauma Nail System
    K151131 PRECICE Intramedullary Limb Lengthening System
    K150885 MAGEC 2 Spinal Bracing and Distraction System
    K150656 PRECICE Intramedullary Limb Lengthening System
    K142599 PRECISE Trauma Nail System