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

    LDR SPINE SPINETUNE TL SPINAL SYSTEM

    K Number: K120760 · Decision Jun 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    10
    Review Days
    106

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    Basic Information

    Device Name
    LDR SPINE SPINETUNE TL SPINAL SYSTEM
    K Number
    K120760
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ldr Spine USA, Inc.
    Date Received
    March 13, 2012
    Decision Date
    June 27, 2012
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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