BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P000058 · Supplement: S033 · Decision Oct 21, 2009
    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
    S033
    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
    October 21, 2009
    Date Received
    March 25, 2009
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE KITTING AND STORAGE LOCATION FOR INFUSE® BONE GRAFT AND IS INDICATED FOR TREATING ACUTE, OPEN TIBIAL SHAFT FRACTURES THAT HAVE BEEN STABILIZED WITH IM NAIL FIXATION AFTER APPROPRIATE WOUND MANAGEMENT, AN ALTERNATIVE TO AUTOGENOUS BONE GRAFT FOR SINUS AUGMENTATIONS, AND FOR LOCALIZED ALVEOLAR RIDGE AUGMENTATIONS FOR DEFECTS ASSOCIATED WITH EXTRACTION SOCKETS, AND FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE AT ONE LEVEL FROM L4-S1.

    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