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510(k) Data Aggregation

    K Number
    K213266
    Device Name
    Inspan ScrewLES Fusion System
    Manufacturer
    LESpine Innovations, LLC
    Date Cleared
    2021-12-03

    (64 days)

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

    LESpine Innovations, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Inspan ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radios), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.
    Device Description
    The Inspan ScrewLES Fusion System, previously cleared (under K102020) and marketed as, "Vega™ SPANTM Spinous Process Plate System", consists of varying length and hub diameters, set screws, and instruments required for implantation. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating postoperatively. The device is offered with varying lengths and hub diameters to accommodate anatomical needs. Set screws are used to secure the two sides of the device into the final compressed and implanted construct. System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.
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