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

    POLARIS SPINAL SYSTEM

    K Number: K131615 · Decision Sep 4, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    18
    Applicant Total
    13
    Review Days
    93

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    Basic Information

    Device Name
    POLARIS SPINAL SYSTEM
    K Number
    K131615
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Spine (Aka Ebi, LLC)
    Date Received
    June 3, 2013
    Decision Date
    September 4, 2013
    Product Code
    OSH
    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
    OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

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