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510(k) Data Aggregation

    K Number
    K240958
    Device Name
    Locking Plates and Screws Systems
    Date Cleared
    2025-02-10

    (308 days)

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

    Hebei Ruihe Medical Devices Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Locking Plates and Screws Systems is intended to provide fixation during fractures, fusions, and osteotomies. Locking Plates and Screws Systems is indicated for the clavicle, and small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
    Device Description
    Locking Plates and Screws Systems consists of metal locking plates, metal locking screws and non-locking metal screws, of which the metal locking plates offered are divided into ordinary type and limited-contact type. The locking plates are made of pure titanium material (TA3G per ASTM F67), and the metal bone screws are made of titanium-alloy (TC4 per ASTM F136). The product surface is color anodized, and the delivery state of the product is non-sterile.
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