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510(k) Data Aggregation

    K Number
    K051093
    Device Name
    OSTEOPORE PCL SCAFFOLD
    Manufacturer
    OSTEOPORE, INC.
    Date Cleared
    2006-03-17

    (323 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOPORE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osteopore PCL Scaffold™ Bone Filler is intended for the use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.
    Device Description
    The Osteopore PCL Scaffold™ is a bone void filler. The Shape of the Osteopore PCL Scaffold™ conforms to the defect, thus maximizing direct contact with viable host bone.
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