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510(k) Data Aggregation

    K Number
    K142502
    Device Name
    ALIANS ULNA LOCKING PLATING SYSTEM
    Manufacturer
    NEWCLIP TECHNICS
    Date Cleared
    2014-12-23

    (109 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K011335,K061917,K100944,K130774
    Predicate For
    K211592
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Alians Ulna Locking Plating System is intended for ulnar shortening osteotomy.

    Device Description

    The Alians Ulna Locking Plating system consists of a plate with many screws as holes (slots) designed for ulnar shortening osteotomy. The plates and screws are manufactured from titanium alloy and color anodized. The Alians Ulna Locking Plating system will be provided non-sterile for sterilization by health care professional's prior use.

    AI/ML Overview

    This document is a 510(k) premarket notification for the "Alians Ulna Locking Plating System". It does not describe a study involving an AI/ML device that requires acceptance criteria. Instead, it describes a medical device (a plating system for bone fixation) and the non-clinical tests performed to demonstrate its substantial equivalence to previously marketed predicate devices.

    Therefore, I cannot provide a response based on your request, as the provided input does not contain information about an AI/ML device study, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as outlined in your prompt.

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