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510(k) Data Aggregation

    K Number
    K183049
    Device Name
    Reliance Lumbar IBF System
    Manufacturer
    Reliance Medical Systems LLC
    Date Cleared
    2019-02-15

    (105 days)

    Product Code
    MAX, ODP, OVE
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Reliance Medical Systems LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reliance Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
    Device Description
    The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is either made of PEEK OPTIMA LT1 with Tantalum markers or with PEEK OPTIMA LT1-HA with Tantalum markers.
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