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510(k) Data Aggregation

    K Number
    K022665
    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOHENSTEIN ENTERPRISES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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