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510(k) Data Aggregation

    K Number
    K102688
    Date Cleared
    2010-12-03

    (77 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K081513, K090063

    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

    The Merete Locking Bone Plate System II consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures for Merete 3.0mm and 3.5mm locking screws (K081513) and cannulated 3.0mm compression screws (K090063). The system is made of titanium alloy Ti-6Al-4V and unalloyed titanium.

    AI/ML Overview

    This document is a 510(k) summary for the Merete Locking Bone Plate System II. It describes a medical device, specifically a bone plate system, and its intended use. There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text.

    The document focuses on:

    • Identifying the device and its manufacturer.
    • Listing predicate devices to establish substantial equivalence.
    • Describing the device's materials and technological characteristics (stating they are similar to predicate devices).
    • Stating its intended use (fixation of fractures, revision procedures, etc., in small bones).
    • Providing FDA correspondence regarding its 510(k) clearance.

    Therefore, I cannot provide the requested table and study details as they are not present in the given input.

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