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510(k) Data Aggregation

    K Number
    K203373
    Device Name
    Advanced Research Medical Trident SI Screw System
    Date Cleared
    2021-01-22

    (67 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Advanced Research Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Advanced Research Medical Trident SI Screw System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
    Device Description
    The Advanced Research Medical Trident SI Screw System consists of screws manufactured from Ti-6Al-4V ELI per ASTM F136. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy.
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    K Number
    K173947
    Device Name
    Lumbar Interbody Fusion System (OLLIF)
    Date Cleared
    2018-07-25

    (210 days)

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

    Advanced Research Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
    Device Description
    The Lumbar Interbody Fusion System consists of instruments and Titanium Alloy (Ti-6Al-4V per ASTM F136) implants which will be offered in twenty-four (24) size configurations to accommodate individual patient anatomy. The implants are designed to facilitate a specific surgical technique, the Oblique Lateral Lumbar approach (OLLIF). The implants are single use and the system is provided non-sterile.
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