LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K141880

    Validate with FDA (Live)

    Device Name
    BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2015-04-16

    (279 days)

    Product Code
    KKY
    Regulation Number
    878.3500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K160988,K161446
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Biopor® Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.

    Device Description

    Porous High Density Polyethylene (HDPE) Surgical Implant

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter for the Biopor® Porous Polyethylene Implants, indicating substantial equivalence to a predicate device. It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1