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510(k) Data Aggregation

    K Number
    K240453
    Device Name
    ReBOSSIS
    Manufacturer
    OrthoRebirth Co., Ltd.
    Date Cleared
    2024-03-04

    (18 days)

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

    OrthoRebirth Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ReBOSSIS is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ReBOSSIS is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities, pelvis, posterolateral spine, and intervertebral disc space). In the extremities and pelvis ReBOSSIS may be used without hydration or hydrated with blood. In the posterolateral spine and intervertebral disc space, ReBOSSIS is to be used hydrated with bone marrow aspirate and mixed with autograft bone. When used in intervertebral body fusion procedures, ReBOSSIS must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
    Device Description
    ReBOSSIS is composite material consisting of beta-tricalcium phosphate (B-TCP), siloxanecontaining vaterite (a form of calcium carbonate, CaCO3), and a resorbable scaffold of poly(Llactide-co-glycolide), or PLGa. The electrospinning process used in manufacturing ReBOSSIS results in a glass wool-like (or cotton ball-like) physical form. Due to its physical form, ReBOSSIS is flexible and can easily adapt to and fill in defects in appropriate amounts.
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    K Number
    K172573
    Device Name
    ReBOSSIS85
    Manufacturer
    Orthorebirth Co., Ltd.
    Date Cleared
    2017-12-15

    (109 days)

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

    Orthorebirth Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ReBOSSIS85 is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. ReBOSSIS85 is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities, pelvis, and posterolateral spine). In the extremities and pelvis ReBOSSIS85 may be used without hydrated with blood. In the posterolateral spine ReBOSSIS85 is to be used hydrated with bone marrow aspirate and mixed with autograft bone. The device provides a bone void filler that is resorbed with host bone during the healing process.
    Device Description
    ReBOSSIS85 is a synthetic, resorbable bone void filler. It is composite material consisting of (by weight) 40% beta-tricalcium phosphate (B-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide-co-glycolide). The electrospinning process used in manufacturing ReBOSSIS85 results in a glass wool-like physical form. Due to its physical form, ReBOSSIS85 is flexible and can easily fill defects in appropriate amounts. ReBOSSIS85 is provided sterile for single-patient, single-use.
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    K Number
    K170620
    Device Name
    ReBOSSIS85
    Manufacturer
    ORTHOREBIRTH Co., Ltd.
    Date Cleared
    2017-06-23

    (114 days)

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

    ORTHOREBIRTH Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ReBOSSIS85 is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. ReBOSSIS85 is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities and pelvis), and may be used without hydrated with blood. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
    Device Description
    ReBOSSIS85 is a synthetic, resorbable bone void filler. It is composite material consisting of (by weight) 40% beta-tricalcium phosphate (8-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide-co-glycolide). The electrospining process used in manufacturing ReBOSSIS85 results in a glass wool-like physical form. Due to its physical form, ReBOSSIS85 is flexible and can easily fill defects in appropriate amounts. ReBOSSIS85 is provided sterile for single-patient, single-use.
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    K Number
    K142090
    Device Name
    REBOSSIS
    Manufacturer
    ORTHOREBIRTH CO., LTD.
    Date Cleared
    2014-10-29

    (89 days)

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

    ORTHOREBIRTH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REBOSSIS is a bone void filler intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. REBOSSIS is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities and pelvis), and may be used without hydration or hydrated with bone marrow aspirate or blood. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
    Device Description
    REBOSSIS is a synthetic, resorbable bone void filler. It is composite material consisting of (by weight) 40% beta-tricalcium phosphate (B-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide). The electrospinning process used in manufacturing REBOSSIS results in a glass wool-like physical form. Due to its physical form, REBOSSIS is flexible and can easily fill defects in appropriate amounts.
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