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510(k) Data Aggregation

    K Number
    K143547
    Device Name
    Vivorte Trabexus EB
    Manufacturer
    VIVORTE, INC
    Date Cleared
    2015-01-14

    (30 days)

    Product Code
    MBP, MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVORTE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vivorté Trabexus™ EB" is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté Trabexus™ EB™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté Trabexus™ EB" may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté Trabexus " EB" is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.
    Device Description
    Vivorté Trabexus™ EB™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). The device is provided in kit sizes of 3 cc. 5 cc. and 10 cc. corresponding to the amount of bone void filler produced when the components of the kit are mixed together.
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    K Number
    K143549
    Device Name
    Vivorte Trabexus
    Manufacturer
    VIVORTE, INC
    Date Cleared
    2015-01-14

    (30 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVORTE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vivorté Trabexus" is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorté Trabexus" is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté Trabexus™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté Trabexus" is resorbed and remodeled by the body as new bone formation occurs during the healing process.
    Device Description
    Vivorté Trabexus™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler. The device is provided in kit sizes of 3 cc, 5 cc, and 10 cc, corresponding to the amount of bone void filler produced when the components of the kit are mixed together.
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    K Number
    K130703
    Device Name
    VIVORTE BVF
    Manufacturer
    VIVORTE, INC
    Date Cleared
    2013-09-12

    (181 days)

    Product Code
    MBP, MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVORTE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vivorté BVF™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.
    Device Description
    Vivorté BVF™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ isothermically hardens in vivo to form a composite of a carbonated apatite (hydroxyapatite) and shaped particles of human bone that contain DBM. Vivorté BVF™ has a compressive and bending strength that is greater than that of human cancellous bone. The carbonated apatite (hydroxyapatite) which closely resembles the mineral phase of bone provides an osteoconductive scaffold and the shaped particles of human bone contain osteoinductive demineralized bone matrix (DBM). The composite device is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together. Each lot of allograft human bone in the Vivorté BVF™ is assayed for osteoinductive potential using an athymic mouse or rat model. The results of the osteoinductive potential testing may or may not be indicative of the osteoinductivity of Vivorté BVF™ in humans.
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    K Number
    K131133
    Device Name
    VIVORTE BVF LITE
    Manufacturer
    VIVORTE, INC
    Date Cleared
    2013-08-12

    (111 days)

    Product Code
    MQV, MOV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVORTE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorte BVF™ Lite™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ Lite™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ Lite™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.
    Device Description
    Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler. Vivorté BVF™ Lite™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ Lite™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ Lite™ isothermally hardens in vivo to form a carbonated apatite (hydroxyapatite). Vivorté BVF™ Lite™ has a compressive and bending strength that is greater than that of human cancellous bone. The carbonated apatite (hydroxyapatite), which closely resembles the mineral phase of bone, provides an osteoconductive scaffold for bone healing. The device is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ Lite™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together.
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