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510(k) Data Aggregation

    K Number
    K253611

    Validate with FDA (Live)

    Device Name
    Falco Fusion System
    Manufacturer
    Mcnicoll Surgical, Inc.
    Date Cleared
    2026-01-29

    (72 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K181881,K201538,K213590
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Falco Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

    Device Description

    The Falco Fusion System is designed to stabilize or fuse the sacroiliac (SI) joint, helping to reduce pain and improve mobility in patients suffering from SI joint disruptions or degenerative sacroiliitis. The system includes titanium alloy screws (Ti-6Al-4V ELI, ASTM F-136) in diameters of 11mm and 13mm, with lengths ranging from 35mm to 75mm. Additionally, the system comes with disposable Kirschner wires (316-LVM, ASTM F138) and reusable surgical (Stainless Steel, ASTM F899) instruments, providing a comprehensive solution for sacroiliac joint fusion procedures.

    AI/ML Overview

    N/A

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