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510(k) Data Aggregation

    K Number
    K013960
    Device Name
    APATIGHT HA-BONE GRAFT SUBSTITUTE
    Manufacturer
    CERABIO, LLC
    Date Cleared
    2002-05-23

    (171 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why 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
    K013966
    Device Name
    APATIGHT-TCP BONE GRAFT SUBSTITUTE
    Manufacturer
    CERABIO, LLC
    Date Cleared
    2002-05-16

    (164 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why 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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