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510(k) Data Aggregation

    K Number
    K091636
    Device Name
    OSTENE CT, AOC CT, OSTEOTENE, CERETENE
    Manufacturer
    CEREMED INC.
    Date Cleared
    2009-06-22

    (18 days)

    Product Code
    MTJ, PRE
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CEREMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSTENE®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
    Device Description
    Ostene®CT is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. Ostene®CT is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. * Ostene® CT contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each. As a bone hemostasis agent, Ostene®CT stops bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. Ostene CT, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding. Ostene®CT is provided sterile by irradiation and must not be resterilized. * A substitution has been made in a neutral excipient copolymer.
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    K Number
    K070093
    Device Name
    OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE
    Manufacturer
    CEREMED INC.
    Date Cleared
    2007-01-24

    (14 days)

    Product Code
    KHJ, MTJ
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    CEREMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSTENE® is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
    Device Description
    Ostene is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. Ostene is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. Ostene contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each. As a bone hemostasis agent, Ostene stops bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. Ostene, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding. Ostene is provided sterile by irradiation and must not be resterilized.
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    K Number
    K041363
    Device Name
    AOC BONE WAX
    Manufacturer
    CEREMED INC.
    Date Cleared
    2004-07-27

    (67 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CEREMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AOC Bone Wax is intended for use in the control of bleeding from bone surfaces.
    Device Description
    Desertifican of this an odorless, opaque wax-like material designed to be utilized directly AOC Done Wage. It is best used immediately following removal from the package, and our of the packager over cased in stickiness by additional handling and manipulation, if so can be of ence wax is provided sterile by irradiation and must not be resterilized. Used for over 100 years, bone waxes stop bone bleeding by the creation of a physical Osed for over he edges of bones that have been damaged by trauma or cut during a surgical procedure. The wax, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
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