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510(k) Data Aggregation

    K Number
    K222987
    Device Name
    Akunah REFLECT
    Manufacturer
    Akunah PTY LTD
    Date Cleared
    2023-05-10

    (224 days)

    Product Code
    LLZ, QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Akunah PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Akunah Reflect Planning Software is intended to be used as a pre-surgical planner for shoulder arthroplasty, fracture, deformity correction and stabilisation procedures. The software is used to assist in the positioning of shoulder components. Akunah Reflect Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. The software leads to the generation of a planning report. The software is to be used for adult patients only and should not be used for diagnostic purposes. Akunah Reflect should be used in conjunction with expert clinical judgement.
    Device Description
    Akunah REFLECT Software is intended to be used as a pre-surgical planner for shoulder arthroplasty, fracture, deformity correction and stabilisation procedures. The user interface software is connected to an online management system (OMS), and is intended to be used by orthopaedic surgeons as a preoperative planning software for shoulder surgery. The software is intended to allow surgeons to: - Visualize, measure, reconstruct, and annotate anatomic data, - Select and position shoulder implant devices, - . Output pre-surgical planning reports The software is to be used for adult patients only and should not be used for diagnostic purpose.
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