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510(k) Data Aggregation

    K Number
    K050681
    Device Name
    OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
    Manufacturer
    TRIMED, INC.
    Date Cleared
    2005-07-27

    (133 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K991964,K792022,K021626,K001941,K961941,K991873,K021321
    Why did this record match?
    Device Name :

    OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES

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

    Omnitech System: The Omnitech Small Fragment Osteosynthesis System is intended for use in the internal fixation of small bones in the hand and foot.

    EasyLock Osteosystem & Xtremities: The Easy Lock and Xtremities implants may be used for permanent or temporary osteosynthesis of small bones, tarsal and carpal fractures, and for the fixation of osteotomies or arthrodesis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for medical devices (Omnitech and Easy Lock Osteosystem). It describes the intended use and establishes substantial equivalence to predicate devices. It does not contain information on acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory submission and equivalence, not on performance study details.

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