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    K Number
    K071184
    Device Name
    SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2007-06-22

    (53 days)

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

    SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM

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

    Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

    Device Description

    Synthes VA-LCP Distal Radius System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the distal portion of the radius. Synthes VA-LCP Distal Radius System enhances fragment-specific fracture fixation by providing the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole.

    AI/ML Overview

    This document is a 510(k) summary for the Synthes Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System. It describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information. This document focuses on the regulatory clearance process based on substantial equivalence, rather than performance testing against specific acceptance criteria.

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