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510(k) Data Aggregation

    K Number
    K031751
    Device Name
    RAPIDFIRE SELF DRILLING SCREWS
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Date Cleared
    2003-06-26

    (21 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K013954
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Internal fixation devices to aid the surgeon in the stabilization of oral craniomaxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, fingers and toes, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.

    Device Description

    The self drilling screws are 1.5 mm to 2.0 mm in diameter and the thread lengths may range up to 7mm. The head may be center drive or cross drive. The screw is designed so that a predrilled hole is not required, but may be used. Five screws are placed within a disposable cartridge A disposable screwdriver blade is loaded between each screw. The cartridges are delivered to the user sterile. The cartridge is loaded into a driver blade system for delivery to the patient.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or a study demonstrating that the device meets acceptance criteria. The document is a 510(k) premarket notification for a medical device (Rapidfire Self Drilling Screws), primarily detailing its intended use, description, potential risks, and the FDA's substantial equivalence determination.

    Therefore, I cannot provide the requested information.

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