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510(k) Data Aggregation

    K Number
    K040134
    Device Name
    THERILINK BONE VOID FILLER
    Manufacturer
    Date Cleared
    2004-03-09

    (48 days)

    Product Code
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TheriLink™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriLink™ parts create a network within the defect site that resorbs during healing and is replaced by bone.
    Device Description
    The TheriLink™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate (ß-TCP), a commonly found mineral in bone. The porosity and geometric features of ß-tricalcium phosphate create a network within the defect site that resorbs during healing and is replaced by native bone.
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    K Number
    K031040
    Device Name
    THERIFIL BONE FILLER
    Manufacturer
    Date Cleared
    2003-07-24

    (114 days)

    Product Code
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TheriFil™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriFil™ parts create an interlocking network within the defect site that resorbs during healing and is replaced by bone.
    Device Description
    The TheriFil™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate, a commonly found mineral in bone. The porosity and geometric features of B-tricalcium phosphate create an interlocking network within the defect site that resorbs during healing and is replaced by native bone.
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    K Number
    K023998
    Device Name
    THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE
    Manufacturer
    Date Cleared
    2003-03-26

    (113 days)

    Product Code
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TheriRidge™ Block Bone Graft Substitute is indicated and intended for the augmentation of deficient maxillary and mandibular alveolar ridges.
    Device Description
    The TheriRidge™ Block device consists of hydroxylapatite material, the primary mineral content of human bone, with porosity and geometric features that encourage tissue in-growth. The device will be available in three (3) basic sizes: small (approximately 10.4 mm x 5.6 x 5.0), medium (approximately 10.4 mm x 10.0 x 5.0), and large (approximately 20.0 mm x 10.0 x 5.0).
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