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510(k) Data Aggregation

    K Number
    K151584
    Device Name
    AttraX Putty
    Manufacturer
    PROGENTIX ORTHOBIOLOGY B.V.
    Date Cleared
    2015-10-08

    (119 days)

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

    PROGENTIX ORTHOBIOLOGY B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AttraX Putty is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects resulting from traumatic injury to the bone. AttraX Putty is intended to be used in conjunction with autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. AttraX Putty provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
    Device Description
    AttraX Putty is a synthetic, osteoconductive and resorbable bone void filler device consisting of ceramic granules premixed with a polymeric binder that provides cohesion between the granules of AttraX Putty are composed of beta-tricalcium phosphate (beta-TCP > 90%) and hydroxyapatite (HA <10 %). The granule size range is from 500 to 1000 um. The premixed binder is alkylene oxide copolymer (AOC). AttraX Putty is provided in various configurations as cylinders, strips, and blocks.
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    K Number
    K090641
    Device Name
    CURIOS
    Manufacturer
    PROGENTIX ORTHOBIOLOGY B.V.
    Date Cleared
    2009-10-23

    (227 days)

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

    PROGENTIX ORTHOBIOLOGY B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CuriOs is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. CuriOs is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. CuriOs is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., posterolateral spine and pelvis) and as an autologous bone graft extender in the posterolateral spine. CuriOs should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. In load bearing situations, CuriOs is to be used in conjunction with internal or external fixation devices.
    Device Description
    CuriOs™ is a micro-structured calcium phosphate resorbable bone void filler for the repair of bony defects. The product comprises of a betatricalcium phosphate and hydroxyapatite. The product is provided sterile.
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