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

    PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM

    K Number: K133289 · Decision Dec 9, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    13
    Review Days
    45

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    Basic Information

    Device Name
    PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
    K Number
    K133289
    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, Inc.
    Date Received
    October 25, 2013
    Decision Date
    December 9, 2013
    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, Inc.

    K Number Device Name
    K160325 PRECICE Intramedullary Limb Lengthening System
    K141278 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
    K141739 RESIDUAL LIMB LENGTHENING SYSTEM
    K140613 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
    K141447 PRECICE TRAUMA NAIL SYSTEM
    K141023 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
    K140178 ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
    K131490 ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
    K131677 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
    K113219 ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
    Search all 13 clearances from Ellipse Technologies, Inc. →