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510(k) Data Aggregation

    K Number
    K092247
    Device Name
    SYNTHES LOCKING HAND PLATES
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2009-09-25

    (59 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 LOCKING HAND PLATES

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

    The Synthes Locking Hand Plates are intended for fixation of fractures, osteotomies, non-unions, replantations and fusions of small bones and small bone fragments, particularly in osteopenic bone.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Synthes (USA) regarding their Locking Hand Plates. This document confirms the device's substantial equivalence to predicate devices and outlines general regulatory compliance.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The letter is an administrative approval, not a technical report detailing performance evaluations.

    Therefore, I cannot provide the requested information based on the input text.

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