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510(k) Data Aggregation
K Number
K141725Device Name
BONGOLD BONE GRAFT MATERIAL
Date Cleared
2015-07-09
(378 days)
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
**BEIJING ALLGENS MEDICAL SCIENCE **& TECHNOLOGY CO, L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Bongold is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the pelvis and extremities. Bongold must be used with autograft as a bone graft extender in the extremities. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bongold resorbs and is replaced with bone during the healing process.
Device Description
Bongold™ Bone Graft Material is a composite of synthetic hydroxyapatite [Ca10(PO4)6(OH)2] and type I collagen. The composite material is a resorbable, porous, osteoconductive bone graft matrix. It is available as a lyophilized matrix in particle forms, cylinders and blocks. This bone graft material contains approximately 45% mineral by weight. Bongold"10 device is intended to be used as bone void filler for voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e., the pelvis, and/or extremities).
Bongold™ cylinders and blocks can be cut into shapes and are designed to retain their shape and physical integrity following implantation into a bony site, while the particle form can be packed to fit the bone defect. The product is sterile and for single use only.
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