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510(k) Data Aggregation

    K Number
    K123633
    Device Name
    TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
    Manufacturer
    TISSUE REGENERATION SYSTEMS, INC.
    Date Cleared
    2013-08-16

    (266 days)

    Product Code
    GXR
    Regulation Number
    882.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    TISSUE REGENERATION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRS Cranial Bone Void Filler is intended for use in the repair of 13mm neurosurgical cranial burr holes. It should be gently packed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.
    Device Description
    TRS Cranial Bone Void Filler (TRS C-BVF) is a synthetic, porous, osteoconductive, bone void filler made from PCL polycaprolactone (CaH100-)X which will degrade and resorb fully in vivo by hydrolysis and is subsequently metabolized by the body, and hydroxylapatite (Ca10(PO4)6.(OH)2) with a calcium phosphate bone mineral coating (Hydroxylapatite and Octacalcium phosphate). TRS BVF has an interconnected porous structure that acts as an osteoconductive matrix for the ingrowth of bone. TRS C-BVF is available in single size, which is a 13mm diameter x 5mm "plug" with a 20mm diameter x .90mm thick flange. TRS C-BVF is manufactured using a laser sintering process and is then coated with the calcium phosphate bone mineral coating. The product is shipped to a contract manufacturer who packages, labels and sterilizes the C-BVF devices. They are then returned to TRS and inventoried as Finished Goods.
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