Search Results
Found 4 results
510(k) Data Aggregation
K Number
K240453Device Name
ReBOSSIS
Manufacturer
OrthoRebirth Co., Ltd.
Date Cleared
2024-03-04
(18 days)
Product Code
MQV
Regulation Number
888.3045Why 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.
Ask a Question
K Number
K172573Device Name
ReBOSSIS85
Manufacturer
Orthorebirth Co., Ltd.
Date Cleared
2017-12-15
(109 days)
Product Code
MQV, MOV
Regulation Number
888.3045Why 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.
Ask a Question
K Number
K170620Device Name
ReBOSSIS85
Manufacturer
ORTHOREBIRTH Co., Ltd.
Date Cleared
2017-06-23
(114 days)
Product Code
MQV, MOV
Regulation Number
888.3045Why 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.
Ask a Question
K Number
K142090Device Name
REBOSSIS
Manufacturer
ORTHOREBIRTH CO., LTD.
Date Cleared
2014-10-29
(89 days)
Product Code
MQV
Regulation Number
888.3045Why 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.
Ask a Question
Page 1 of 1