BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P000058 · Supplement: S065 · Decision Sep 21, 2017
    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 (R) Bone Graft
    PMA Number
    P000058
    Supplement Number
    S065
    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
    September 21, 2017
    Date Received
    April 28, 2017
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for expansion of the approved indications for use of Infuse Bone Graft to include implantation with two additional interbody fusion devices, the Divergence-L Anterior/Oblique Lumbar Fusion System or the Pivox Oblique Lateral Spinal System, utilizing select open surgical procedures in conjunction with supplemental spinal fixation hardware, as well as modifying the surgical technique manual to allow surgeons to optionally wrap a resorbable suture around the fusion cage component to maintain the position of the Infuse Bone Graft within the central cavity of the fusion cage component.

    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