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510(k) Data Aggregation

    K Number
    K211845
    Device Name
    Deploy Expandable Interbody System
    Manufacturer
    Date Cleared
    2021-11-16

    (154 days)

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

    Southern Spine LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Deploy™ Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with degenerative disease (DDD) at one level or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients should be skeletally mature and have at least six months of non-operative treatment prior to being treated with this system. Additionally, the Deploy™ implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Deploy™ implants are intended to be used with supplemental spinal fixation systems that are cleared for use in the lumbosacral spine.
    Device Description
    The Deploy™ Expandable Interbody System is comprised of the interbody implant cages, surgical instruments which include trial instruments to aid in the selection of the appropriate implant size for the patient's anatomy, and sterilization trays. The implants are manufactured from titanium alloy Ti-6AI-4V (ASTM F136, ASTM F3001) and are offered with various heights and shapes for different patient anatomy. Each implant is designed to be inserted and then rotate in-situ, providing immediate fixation and the arm deployed for the graft containment area. Ridges on the superior and inferior surfaces of the titanium implants contact the endplates to resist expulsion forces. The implants are designed to be used in conjunction with supplemental spinal fixation instrumentation. The surgical instruments are manufactured from stainless steel (ASTM F899. ISO 7153-1). The implants and surgical instruments are provided non-sterile and require sterilization prior to use within sterilization trays following validated sterilization parameters as provided within the Instructions for Use.
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