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510(k) Data Aggregation

    K Number
    K241599
    Device Name
    Signature Osteosynthesis Plate System
    Date Cleared
    2025-02-06

    (247 days)

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

    Signature Orthopaedic Pty Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Signature Osteosynthesis Plate System is intended for adult patients for internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions. The 1/3 Tubular Plate and Compression Plate Small are internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of the Foot, hand, wrist, and forearm. Additionally, the Compression Plate Narrow and Compression Plate Broad are internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of the upper extremity and lower extremity, except for the femur and proximal tibia. The Clavicle Plates are intended for use in fixation of fractures, osteotomies, and non-unions of the clavicle in adult patients in whom the clavicular growth plates have fused or in whom the growth plates can be crossed by the plate system.
    Device Description
    The Signature Osteosynthesis Plate System utilizes screws and plates of various lengths and designs to accommodate a variety of patient anatomies. The System utilizes medical grade Titanium alloy. System implants are provided both sterile and non-sterile with instructions for steam sterilization. The sterile implants are provided sterilized in Tyvek packaging. The implants are single use only.
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