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510(k) Data Aggregation
K Number
K220337Device Name
GaiaBone Bioabsorbable Bone Graft
Manufacturer
Date Cleared
2023-02-03
(361 days)
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Corliber (Shenzhen) Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GaiaBoneTM Bioabsorbable Bone Graft is an implant intended to fill bony voids or gaps of the skeletal system. i.e., the pelvis and extremities. These osseous defects may be surgically created of traumatic injury to the bone and are not intrinsic to the stability of the boneTM Bioabsorbable Bone Graft resorbs and is replaced with bone during the healing process.
Device Description
GaiaBone™ Bioabsorbable Bone Graft is a composite of synthetic hydroxyapatite [Ca10(PO4)6(OH)2] and lactide-caprolactone copolymer. The composite material is a shapable, absorbable, osteoconductive putty bone graft. It is available in cylinders. This bone graft material contains approximately 50% mineral by weight. GaiaBone™ Bioabsorbable Bone Graft 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).
GaiaBone™ is easy to be shaped and designed to retain its shape and physical integrity following implantation into a bony site. The product is sterile and for single use only.
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