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510(k) Data Aggregation

    K Number
    K160988
    Device Name
    Biopor, AOC Porous Polyethylene, Cerepor
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2016-07-14

    (97 days)

    Product Code
    KKY
    Regulation Number
    878.3500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Biopor Porous Polyethylene Implants are manufactured of porous high-density polyethylene, a biomaterial that is easily contoured or carved to suit the anatomical and functional requirements of the patient. The interconnecting pores of the Porous HDPE material permits fibrovascular ingrowth into the implant. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend and/or the option of embedded titanium mesh. AOC™ Porous Polyethylene Surgical Implants are provided STERILE and should not be resterilized.
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    K Number
    K141880
    Device Name
    BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2015-04-16

    (279 days)

    Product Code
    KKY
    Regulation Number
    878.3500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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    K Number
    K132198
    Device Name
    ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2013-09-12

    (58 days)

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

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adaptain" is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
    Device Description
    Adaptain™ is a water-soluble, wax-like surgical implant material that will adhere to itself utilized directly and a first application of firm pressure. Adaptain " is designed to be utilized directly out of the package. The implant will soften as it is warmed. The surface of the implant becomes lubricious when wet, and the implant does not swell as it dissolves. Adaptain™ is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend™) and contains no other additives or colorants. Adaptain is supplied in a number of forms including bars, sticks, granules and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain™ is provided sterile by irradiation and must not be resterilized.
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    K Number
    K122561
    Device Name
    ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2012-11-27

    (97 days)

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

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adaptain FastWrap™ is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
    Device Description
    Adaptain FastWrap™ 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. Adaptain FastWrap "" is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain FastWrap " contains no other additives or colorants. Adaptain FastWrap™ is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain FastWrap is provided sterile by irradiation and must not be resterilized.
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    K Number
    K120220
    Device Name
    ADAPTAIN SOLUBLE IMPLANT MATERIAL
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2012-06-06

    (133 days)

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

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adaptain™ Soluble Implant Material is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
    Device Description
    Adaptain™ Soluble Implant Material 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. Adaptain" Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain" "Soluble Implant Material contains no other additives or colorants. Adaptain"" Soluble Implant Material is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain™ Soluble Implant Material is provided sterile by irradiation and must not be resterilized.
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    K Number
    K103047
    Device Name
    CERETENE SOLUBLE IMPLANT MATERIAL
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2011-01-05

    (82 days)

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

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ceretene" Soluble Implant Material is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
    Device Description
    Ceretene" Soluble Implant Material 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. Ceretene" Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC). Ceretene™ Soluble Implant Material contains no other additives or colorants. Ceretene" Soluble Implant Material is formed in bars and sheets of various weights ranging from 0.5 to 5 grams each. Ceretene" Soluble Implant Material is provided sterile by irradiation and must not be resterilized.
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    K Number
    K102071
    Device Name
    OSTENE CT, AOC CT, OSTEOTENE, CERETENE
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2010-10-08

    (77 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
    OSTENE®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces in cardiothoracic surgery surgery following sternotomy .
    Device Description
    Ostene® CT is a water-soluble surgical implant material for use in cardiothoracic surgery. 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. 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.
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    K Number
    K082491
    Device Name
    OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2008-09-24

    (27 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
    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 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
    K082245
    Device Name
    AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2008-09-18

    (42 days)

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

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AOC" -L is indicated for use as an aqueous water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
    Device Description
    AOC" -L Soluble Implant Material 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. AOC" -L Soluble Implant Material is comprised of a sterile aqueous mixture of watersoluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. AOC" -L Soluble Implant Material contains no other additives or colorants. AOC" -L Soluble Implant Material is formed of various weights ranging from 0.5 to 5 grams each. AOC" -L Soluble Implant Material is provided sterile by irradiation and must not be resterilized.
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    K Number
    K081531
    Device Name
    AOC SOLUBLE IMPLANT MATERIAL
    Manufacturer
    CEREMED, INC.
    Date Cleared
    2008-07-18

    (46 days)

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

    CEREMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AOC "M is indicated for as a water-solubic implant material and as a water-soluble space occupying material, as an adjunct during the natural healing process.
    Device Description
    Not Found
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