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510(k) Data Aggregation

    K Number
    K962011
    Manufacturer
    Date Cleared
    1996-08-05

    (74 days)

    Product Code
    Regulation Number
    888.3040
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHES 7.0/7.3 MM CANNULATED SCREWS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Synthes 7.0/7.3 mm Cannulated Screws are generally intended for fracture fixation of large bones and large bone fragments.

    Device Description

    Synthes 7.0/7.3 mm Cannulated Screws are available in multiple thread length configurations (16 mm, 32 mm or fully threaded). Both Screws feature reverse cutting flutes and cancellous threads. Additionally, the 7.3 mm Cannulated Screw features self-drilling/self-tapping flutes. Both screws are used in conjunction with a guide wire for precise placement in bone. Synthes 7.0/7.3 mm Cannulated Screws are manufactured from stainless steel. The 7.3 mm Cannulated Screw is also available in a titanium alloy.

    AI/ML Overview

    This document is a summary of safety and effectiveness information for a medical device (Synthes 7.0/7.3 mm Cannulated Screws). It does not contain information about a study that uses Artificial Intelligence (AI) or machine learning to meet acceptance criteria through device performance.

    Therefore, I cannot provide the requested information, such as acceptance criteria and device performance in an AI context, sample sizes for test and training sets, expert qualifications, adjudication methods, or ground truth types, because the document describes a traditional mechanical medical device and its mechanical testing, not an AI-powered device.

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