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510(k) Data Aggregation

    K Number
    K240212
    Device Name
    COGNiTiON™ Staple System
    Manufacturer
    Ortho Solutions UK Ltd.
    Date Cleared
    2024-02-23

    (29 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ortho Solutions UK Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ortho Solutions COGNITiON™ Staple System is indicated for hand and foot bone fragments, osteotomy, fixation and joint arthrodesis. The COGNiTiON™ Staple System is not intended for spinal use.
    Device Description
    The COGNITION Staple System is comprised of a set of implantable metallic (Superelastic NiTi Alloy per ASTM F2063) staples and accessory instrumentation. The system consists of a series of two and four-leg staples of various bridge and leg lengths. Each staple is provided to the user in a relaxed state with the staple legs in a converging position. During the staple insertion step, the provided staple driver is used to splay the staple legs, allowing for implantation across the fracture, fusion, or osteotomy site. The staple legs then have the inherent propensity to converge due to the superelastic nature of the NiTi material. This stability is intended to allow for bone healing to occur.
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