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Found 16 results
510(k) Data Aggregation
K Number
K160988Device Name
Biopor, AOC Porous Polyethylene, Cerepor
Manufacturer
CEREMED, INC.
Date Cleared
2016-07-14
(97 days)
Product Code
KKY
Regulation Number
878.3500Why 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
K141880Device Name
BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
Manufacturer
CEREMED, INC.
Date Cleared
2015-04-16
(279 days)
Product Code
KKY
Regulation Number
878.3500Why 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
K132198Device Name
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
Manufacturer
CEREMED, INC.
Date Cleared
2013-09-12
(58 days)
Product Code
KHJ
Regulation Number
874.3620Why 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
K122561Device Name
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
Manufacturer
CEREMED, INC.
Date Cleared
2012-11-27
(97 days)
Product Code
KHJ, PRE
Regulation Number
874.3620Why 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
K120220Device Name
ADAPTAIN SOLUBLE IMPLANT MATERIAL
Manufacturer
CEREMED, INC.
Date Cleared
2012-06-06
(133 days)
Product Code
KHJ, PRE
Regulation Number
874.3620Why 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
K103047Device Name
CERETENE SOLUBLE IMPLANT MATERIAL
Manufacturer
CEREMED, INC.
Date Cleared
2011-01-05
(82 days)
Product Code
KHJ, PRE
Regulation Number
874.3620Why 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
K102071Device Name
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
Manufacturer
CEREMED, INC.
Date Cleared
2010-10-08
(77 days)
Product Code
MTJ
Regulation Number
N/AWhy 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
K082491Device 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/AWhy 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
K082245Device 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
874.3620Why 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
K081531Device Name
AOC SOLUBLE IMPLANT MATERIAL
Manufacturer
CEREMED, INC.
Date Cleared
2008-07-18
(46 days)
Product Code
KHJ
Regulation Number
874.3620Why 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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