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510(k) Data Aggregation
K Number
K233378Device Name
ABCcolla® Collagen ADM Scaffold
Manufacturer
ACRO Biomedical Co., Ltd.
Date Cleared
2024-10-18
(382 days)
Product Code
KGN, DAT
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ACRO Biomedical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ABCcolla® Collagen ADM Scaffold is intended to be used for management of wounds. including venous ulcers, pressure ulcers, chronic vascular ulcers, diabetic ulcers, tunneled undermined wounds (donor site/ grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), first and second-degree burns, draining wounds.
Device Description
ABCcolla® Collagen ADM Scaffold is a decellularized porcine collagen biomaterial from porcine dermis. When applied on a wound, this product helps absorb wound exudates and maintain a moist wound environment.
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K Number
K212156Device Name
ABCcolla Bone Matrix
Manufacturer
ACRO Biomedical Co., Ltd.
Date Cleared
2021-10-08
(88 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
ACRO Biomedical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ABCcolla® Bone Matrix is intended to fill bony voids or gaps of skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of bone structure. ABCcolla® Bone Matrix provides resorbs and is replaced by bone during the healing process.
Device Description
ABCcolla® Bone Matrix is a bone mineral matrix of porcine origin. ABCcolla® Bone Matrx is physically and chemically comparable to the mineralized matrix of human bone.
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K Number
K171629Device Name
ABCcolla Bone Graft
Manufacturer
ACRO Biomedical Co., Ltd.
Date Cleared
2018-02-01
(244 days)
Product Code
MQV, MOV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
ACRO Biomedical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ABCcolla® Bone Graft is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ABCcolla® Bone Graft resorbs and is replaced with bone during the healing process.
Device Description
ABCcolla® Bone Graft is a bone mineral matrix of porcine origin. ABCcolla® Bone Graft is physically and chemically comparable to the mineralized matrix of human bone.
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