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510(k) Data Aggregation

    K Number
    K010869
    Device Name
    EPOCA CUSTOM OFFSET SHOULDER SYSTEM
    Manufacturer
    ARGOMEDICAL AG
    Date Cleared
    2001-10-11

    (202 days)

    Product Code
    KWT
    Regulation Number
    888.3650
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EPOCA Custom Offset Hemi-Shoulder System is a single-use device intended for cemented reconstruction of the humeral portion of severely destroyed (4-part fractures) and/or disabled and/or very painful shoulder joints resulting from osteoarthritis, rheumatoid-arthritis, traumatic arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present. This device is intended for use with components of the EPOCA Custom Offset Hemi-Shoulder System only.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the EPOCA Custom Offset Shoulder System, a traditional medical device (shoulder joint prosthesis) and does not describe acceptance criteria, study details, or performance results typically associated with AI/ML devices. Therefore, I cannot extract the requested information from this document.

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