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510(k) Data Aggregation

    K Number
    K980368
    Device Name
    DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
    Manufacturer
    DEPUY, INC.
    Date Cleared
    1998-04-14

    (74 days)

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

    DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM

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

    The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.

    Device Description

    The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus. The system consists of 3 mm rods, ranging in length from 60mm to 180mm, and 3 styles of rod connectors, classified as right, left, and neutral. The rods are secured to the connectors using a pin nut. Screws are used to secure the connectors to the bone.

    AI/ML Overview

    The provided text is a 510(k) summary for the DePuy Motech PEAK 3mm Fixation Rod System. This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, study methodologies, or performance metrics in the context of an AI-powered medical device or software.

    Therefore, I cannot fulfill your request for the tables and information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies. This document pertains to a physical bone fixation rod system, not a digital diagnostic or AI-driven system.

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