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510(k) Data Aggregation

    K Number
    K253604

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-20

    (122 days)

    Product Code
    Regulation Number
    882.4560
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K231831, K243265, K243580

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

    The TiLink-L Navigation Instruments are intended to be used with the TiLink-L Joint Fusion System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. Fluoroscopy is intended to be used for navigating final implant placement.

    Device Description

    The TiLink-L Navigation Instruments include a Drill Bit, Drill Guide, and Inserter and are specifically designed to be used with the TiLink-L Joint Fusion System Implants. The TiLink-L Navigation Instruments are to be used with the NavLock Instruments and Medtronic StealthStation System S8. The TiLink-L Joint Fusion System is provided sterile (single use) and non-sterile (reusable) and the TiLink-L Navigation Instruments are manufactured from Stainless Steel per ASTM F899.

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