BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Bone Void, Non-Osteoinduction

    PMA: P900039 · Supplement: S013 · Decision Jun 7, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Filler, Bone Void, Non-Osteoinduction
    Trade Name
    NEUGRAFT
    PMA Number
    P900039
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    MBS
    Generic Name
    Filler, bone void, non-osteoinduction
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 7, 2004
    Date Received
    April 30, 2004
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE PRODUCT "NEUGRAFT". COLLAGRAFT STRIP BONE GRAFT MATRIX (COLLAGRAFT) WAS ORIGINALLY APPROVED BY THE FDA ON JANUARY 27, 1994 (REVIEW OF P900039). THE PRODUCT CURRENTLY CONTINUES TO BE MARKETED BY THAT NAME. NEUGRAFT IS IDENTICAL TO COLLAGRAFT STRIP BONE GRAFT MATRIX, EXCEPT THAT THE BRAND NAME ON THE LABELING IS DIFFERENT. THE LABELING FOR NEUGRAFT INDICATED AND EXPLAINS THAT THE TWO PRODUCTS ARE THE SAME, BUT ARE SOLD THROUGH DIFFERENT DISTRIBUTION CHANNELS. AS PROPOSED, THE PRODUCT WILL CONTINUE TO BE SOLD USING BOTH NAMES COLLAGRAFT AND NEUGRAFT. THERE WILL BE NO CHANGE AFFECTING SAFETY AND EFFECTIVENESS FOR THIS PRODUCT.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MBS Filler, Bone Void, Non-Osteoinduction