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510(k) Data Aggregation

    K Number
    K240181
    Device Name
    Clavicle and Scapula System
    Manufacturer
    Auxein Medical Pvt. Ltd
    Date Cleared
    2024-10-09

    (260 days)

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

    Auxein Medical Pvt. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3.5mm Wise-Lock Scapula Medial Border Plate Indicated to provide fixation during fractures, fusions, and osteotomies for the Scapula. 3.5mm Wise-Lock Clavicle Hook Plate Indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. 2.7 / 3.5mm Wise-Lock Superior Anterior Clavicle Plate with Lateral Extension Indicated for fixation of fractures, malunions, non-unions, and osteotomies for the clavicle. 3.5mm Wise-Lock S Clavicle Plate Indicated to provide fixation for fractures, fusion, or osteotomies for the clavicle.
    Device Description
    Clavicle and Scapula System consists various types of bone plates, Screws for implantation & fixation of Clavicle and Scapula bone fractures. The plates are designed to match the and Scapula bones with a limited contact low profile design. Scapula Plates are featured with only locking holes. However, Clavicle plates are featured with locking holes, combiholes, compression holes as well as static holes for better fixation of implant. All the plates and screws included in the system are available in both Stainless Steel as per ASTM F138 and Titanium material as per ASTM F136. The Scapula System consists of a medial border plate. It also consist of 3.5mm cortical screws, and 4.0 mm Cancellous screws for the fixation of bone plate to the bone. Similarly, the Clavicle system consists of Hook plate, and S Clavicle plate for fixation of clavicle bone. In this system for fixation of bone various lengths of 2.7 & 3.5mm cortical screws, 2.7 & 3.5 mm wise lock screws and 2.7 & 3.5mm AV wise lock screw are used.
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