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510(k) Data Aggregation
K Number
K013960Device Name
APATIGHT HA-BONE GRAFT SUBSTITUTE
Manufacturer
CERABIO, LLC
Date Cleared
2002-05-23
(171 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
CERABIO, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Apatight-HA Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-HA is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.
Device Description
Apatight-HA Bone Graft Substitute is a porous hydroxyapatite bone graft substitute for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile in block and granular forms. Apatight-HA Bone Graft Substitute guides the threedimensional regeneration of bone in the defect site into which it is implanted. When Apatight-HA Bone Graft Substitute is placed in direct contact with viable host bone, new bone grows in apposition to the surfaces of the implant, filling the pores with new bone during the healing process. The product is completely incorporated into the newly formed bone.
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K Number
K013966Device Name
APATIGHT-TCP BONE GRAFT SUBSTITUTE
Manufacturer
CERABIO, LLC
Date Cleared
2002-05-16
(164 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
CERABIO, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Apatight-TCP Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.
Device Description
Apatight–TCP Bone Graft Substitute is a porous calcium phosphate resorbable bone graft substitute for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile in block and granular forms. Apatight-TCP Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Apatight-TCP Bone Graft Substitute is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant, filling the pores with new bone. As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute.
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