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    K Number
    K051836
    Device Name
    SKELITE RESORBABLE CEMENT RESTRICTOR
    Manufacturer
    MILLENIUM BIOLOGIX, INC.
    Date Cleared
    2005-11-21

    (138 days)

    Product Code
    JDK
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLENIUM BIOLOGIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Skelite™ Resorbable Cement Restrictor is intended to be used in orthopaedic surgeries, such as those involving the femoral and tibia canals in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.
    Device Description
    Not Found
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    K Number
    K011726
    Device Name
    MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER
    Manufacturer
    MILLENIUM BIOLOGIX, INC.
    Date Cleared
    2002-05-16

    (346 days)

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

    MILLENIUM BIOLOGIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Skellite™ Synthetic Resorbable Bone Void Filler is indicated only for bony voids on I he Skence - Bynthone reability of the bony structure. Skelite "" is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, be gently paokid into belly veats may be surgically created osseous defects or osseous spine, and pervisy. Theose coloring to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The product can be mixed with bone marrow.
    Device Description
    Not Found
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