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510(k) Data Aggregation

    K Number
    K161446
    Device Name
    Biopor Porous Polyethylene Implants
    Manufacturer
    Date Cleared
    2016-09-27

    (125 days)

    Product Code
    Regulation Number
    882.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ceremed , Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Biopor® Porous Polyethylene Implants in sheet configurations are intended for the augmentation or reconstruction of the craniofacial skeleton, including the cranial skeleton, orbit, nasal bones and the zygoma.
    Device Description
    Biopor® Porous Polyethylene Implants are manufactured of porous high-density polyethylene (PPE), a biomaterial that is contoured or carved to suit the anatomical and functional requirements of the patient. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend (AOC). Biopor® Porous Polyethylene Implants are provided STERILE and must not be resterilized.
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