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510(k) Data Aggregation

    K Number
    K140069
    Device Name
    LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
    Manufacturer
    MERETE MEDICAL GMBH
    Date Cleared
    2014-04-07

    (84 days)

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

    LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0

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

    The Merete Locking Bone Plate System can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) letter for the "Merete Locking Bone Plate System III" does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    The document is a standard FDA clearance letter for a Class II medical device, indicating that the device has been found substantially equivalent to a predicate device. It outlines regulatory requirements and proper labeling but does not delve into the technical details of performance testing or clinical studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided.

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