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510(k) Data Aggregation

    K Number
    K190600
    Device Name
    ORION Spinal System
    Manufacturer
    Date Cleared
    2020-08-18

    (529 days)

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

    Orion Biotech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The "ORION" Spinal System is a non-cervical, pedicle screw system intended to provide posterior, non-cervical immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine : degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; scoliosis; kyphosis; spinal stenosis; tumor; pseudarthrosis and/or failed previous fusion. In addition, the "ORION" Spinal System is also indicated for the treatment of the skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, having fusion by autogenous bone graft, with implant fixed or attached to the lumbar and sacral spine (L3 to Sacrum), and for whom the intended to be removed after solid fusion is achieved.
    Device Description
    The "ORION" Spinal System is a system that is intended to be used for posterior thoracolumbar fusion procedures. The system is manufactured from Ti-6Al-4V which complies with ASTM F136 and PEEK which complies with ASTM F2026. The components, which are included as part of the system, include screws, rods, links, and accessory connection components.
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