BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

    PMA: P000058 · Supplement: S048 · Decision Jul 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
    Trade Name
    INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
    PMA Number
    P000058
    Supplement Number
    S048
    Device Class
    FDA Class 3
    Product Code
    NEK
    Generic Name
    Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 17, 2012
    Date Received
    October 20, 2011
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE IDENTIFIED PRODUCTS.SPECIFICALLY REQUESTED WAS THE FOLLOWING: 1) AN ADDITIONAL WARNING TO ADDRESS CONCERNS RELATED TO THE USE OF POTENTIAL PATIENTS WITH A SUSPECTED MALIGNANCY; 2) AN ADDITIONAL WARNING RELATED TO DEVICE MIGRATION; 3) A MODIFICATION TO THE PRECAUTION RELATED TO ECTOPIC, HETEROTOPIC AND EXUBERANT BONE FORMATION BY REMOVING THE INITIAL QUALIFYING LANGUAGE: AND 4) A MODIFICATION TO THE DESCRIPTION OF THE RECONSTITUTED RECOMBINANT PROTEIN SOLUTION, I.E., "...COLORLESS TO SLIGHTLY YELLOW..."

    Classifications

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

    Product Code Device Name
    NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction