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510(k) Data Aggregation

    K Number
    K251525
    Device Name
    SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
    Manufacturer
    SI-Technology, LLC
    Date Cleared
    2025-06-06

    (18 days)

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

    SI-Technology, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
    Device Description
    The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System consists of an X shaped implant designed to assist in the healing of sacroiliac (SI) joints for fusion by providing fixation of the sacroiliac joint. The implant is not intended to replace normal body structures. The implant is offered in five variations with one size per variation. The implant is manufactured from titanium alloy per ASTM F136. The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System was designed as a less invasive alternative to traditional open posterior surgical SI joint fusion. The titanium implant consists of a sacrum engaging side and an ilium engaging side connected by a bridge. During the procedure, bone graft material is placed in the window of the implant to facilitate stabilization. The implant is intended for single-use only. Implants are provided clean and non-sterile and designed for routine steam sterilization prior to use.
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    K Number
    K241813
    Device Name
    SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
    Manufacturer
    SI-Technology, LLC
    Date Cleared
    2024-08-13

    (53 days)

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

    SI-Technology, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroillac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients underqoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
    Device Description
    The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System consists of an X shaped implant designed to assist in the healing of sacroiliac (SI) joints for fusion by providing fixation of the sacroiliac joint. The implant is not intended to replace normal body structures. The implant is offered in one size. The implant is manufactured from titanium alloy per ASTM F136. The SI-TECHNOLOGY® SI-DESIS® XTM Sacroiliac Joint Fusion System was designed as a less invasive alternative to traditional open posterior surgical SI joint fusion. The titanium implant consists of a sacrum engaging side and an ilium engaging side connected by a bridge. During the procedure, bone graft material is placed in the window of the implant to facilitate stabilization. The implant is intended for single-use only. Implants are provided clean and non-sterile and designed for routine steam sterilization prior to use.
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    K Number
    K151462
    Device Name
    SI-TECHNOLOGY® SI-DESIS® SCREWS
    Manufacturer
    SI-TECHNOLOGY, LLC
    Date Cleared
    2015-08-12

    (72 days)

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

    SI-TECHNOLOGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SI-TECHNOLOGY® SI-DESIS® Device is intended for sacroiliac joint fusion for conditions including sacroiliac (SI) joint disruptions and degenerative sacroiliitis.
    Device Description
    The SI-TECHNOLOGY® SI-DESIS® Sacroiliac Joint Fusion Screw System consists of screws designed to assist in the healing of sacroiliac joints for fusion by providing fixation of large bones and large bone fragments of the pelvis. The screws are not intended to replace normal body structures. The screws are offered in 6.5 mm diameter cannulated, partially threaded or fully threaded configurations in various lengths. Additionally, optional supplemental 5 mm diameter screws are offered in various lengths and are to be used only in conjunction with the 6.5 mm screws for supplemental screw fixation to accommodate patient anatomy. The screws are manufactured from titanium alloy per ASTM F136.
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