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

    PRECICE Intramedullary Limb Lengthening System

    K Number: K151131 · Decision Jun 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    7
    Review Days
    52

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    Basic Information

    Device Name
    PRECICE Intramedullary Limb Lengthening System
    K Number
    K151131
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ellipse Technologies, Incorporated
    Date Received
    April 28, 2015
    Decision Date
    June 19, 2015
    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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