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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
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (SKELITE™ Synthetic Resorbable Bone Void Filler). This letter does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

    Therefore, I cannot provide the detailed response you're looking for based on this document.

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