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510(k) Data Aggregation

    K Number
    K974030
    Device Name
    CARPAL ENGAGING WRIST FUSION PLATE
    Manufacturer
    TERRAY CORP.
    Date Cleared
    1998-01-21

    (90 days)

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

    CARPAL ENGAGING WRIST FUSION PLATE

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

    The various clinical indications for wrist arthrodesis are at the discretion of the surgeon but in general include:

    • rheumatoid wrist deformities requiring restoration of alignment and stability
    • carpal instabilities
    • severe unremitting wrist pain related to motion of the carpus
    • other damage to the wrist joint including post-traumatic arthrosis, infection and tumor resection.
    Device Description

    Carpal Engaging Wrist Fusion Plate

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Terray Carpal Engaging Wrist Fusion Plate). It does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study designs typically associated with AI/ML device evaluations.

    Therefore, I cannot extract the requested information to fill in the table and answer the questions about a study on device performance.

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