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510(k) Data Aggregation

    K Number
    K162750
    Device Name
    Libra Pedicle Screw System
    Manufacturer
    Spinal Balance, Inc.
    Date Cleared
    2016-10-27

    (27 days)

    Product Code
    NKBMNHMNI
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spinal Balance, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Libra Pedicle Screw System is intended for immobilization of the posterior thoracic, lumbar and sacral/iliac spine (T1-S1/Ilium) in skeletally mature patients as an adjunct to the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
    Device Description
    The Libra Pedicle Screw System consists of longitudinal members (rods), anchors (screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
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