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510(k) Data Aggregation

    K Number
    K124014
    Device Name
    SUREFIX INTERSPINOUS FUSION SYSTEM
    Manufacturer
    Date Cleared
    2013-08-09

    (225 days)

    Product Code
    Regulation Number
    888.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    JG SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SureFix Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The SureFix Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
    Device Description
    The JG Spine SureFix Interspinous Fusion System device is a family of posterior, non-pedicle, supplemental fixation devices that are manufactured from Titanium alloy (per ASTM F136). More specifically, these devices are interspinous process implants that are offered in a variety of diameters and lengths and are clamped to two consecutive non-cervical spinous processes. The system is to be implanted from the posterior approach.
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