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510(k) Data Aggregation

    K Number
    K083694
    Manufacturer
    Date Cleared
    2009-03-06

    (84 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES

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

    The Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

    Device Description

    The Synthes 2.4 mm Variable Angle LCP (VA-LCP) Two-Column Volar Distal Radius Plate is a machined metal plate that is designed for fixation of various fracture modes of the distal portion of the radius. The 2.4 mm VA-LCP Two-Column Volar Distal Radius plate allows fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. Synthes' variable angle locking technology enhances plate-screw construct stability. The plates are manufactured in either titanium or stainless steel.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets them. This document appears to be a 510(k) summary for a medical device (Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plate), which focuses on establishing substantial equivalence to a predicate device rather than detailing performance studies and acceptance criteria. The information provided is primarily regulatory in nature.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I populate the table and other requested sections.

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