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    K Number
    K252758
    Device Name
    Cannulated Screw and Kirschner (K wire) System
    Manufacturer
    OrthoNovis, Inc.
    Date Cleared
    2025-10-02

    (34 days)

    Product Code
    HWC,HTN,HTY
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K130613,K250055,K231504
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula.

    Device Description

    Cannulated Screws and Kwires are a self-tapping, self-drilling screw with a cortico/cancellous or cancellous thread that can be guided into position by Kwire placement. Partial or fully threaded screws are available in various different lengths and diameters to provide fixation in various size bones. The screws are made of Titanium Alloy or Stainless Steel. The Kirschner Wires (Kwires) are threaded, spaded or blunt ranging from 0.8 to 1.4mm in diameter and ranging from 100 to 200mm in length and made of 316L Stainless Steel.

    AI/ML Overview

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