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510(k) Data Aggregation

    K Number
    K984498
    Device Name
    SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    1999-02-18

    (63 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K963618,K942906,K982982
    Why did this record match?
    Device Name :

    SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM

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

    Synthes Articulating Distal Radius Fixator System is intended for stabilizing fractures of the distal radius.

    Device Description

    The Articulating Distal Radius Fixator is a preassembled mechanically adjustable external wrist fixator. It is a one-piece construct, which consists of plastic and metal components. The device is applied to the bone with four self-drilling Schanz Screws that lock into two fixator clamps. The device is operated by turning screws, which operates gears to achieve incremental movement.

    AI/ML Overview

    Based on the provided text, there is no information about acceptance criteria for device performance, a study proving the device meets acceptance criteria, sample sizes, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, or how ground truth was established.

    The document is a 510(k) summary for a medical device (Synthes Articulating Distal Radius Fixator) and an FDA clearance letter. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

    Therefore, I cannot provide the requested table and information.

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