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510(k) Data Aggregation

    K Number
    K022665

    Validate with FDA (Live)

    Device Name
    POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
    Manufacturer
    HOHENSTEIN ENTERPRISES, INC.
    Date Cleared
    2002-10-09

    (61 days)

    Product Code
    KKY
    Regulation Number
    878.3500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K922489
    Predicate For
    K043133,K071937,K183472
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.

    Device Description

    ePor, Inc. Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are manufactured of porous high density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years.

    AI/ML Overview

    This document is a 510(k) submission for Porous HDPE Surgical Implants (K022665). It establishes substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as this document describes a traditional medical device (surgical implants) and not an AI/ML powered device.

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