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P000058 Medtronic Sofamor Danek InFUSE  Bone Graft/LT-Cage Lumbar Tapered Fusion Device

P000058 Medtronic Sofamor Danek InFUSE  Bone Graft/LT-Cage Lumbar Tapered Fusion Device. Restorative Devices Branch Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health. Aric Kaiser, MS - PMA lead reviewer

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P000058 Medtronic Sofamor Danek InFUSE  Bone Graft/LT-Cage Lumbar Tapered Fusion Device

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  1. P000058Medtronic Sofamor DanekInFUSE Bone Graft/LT-Cage Lumbar Tapered Fusion Device Restorative Devices Branch Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

  2. Aric Kaiser, MS - PMA lead reviewer Peter Hudson, PhD - lead preclinical reviewer Barbara Buch, MD - clinical reviewer Telba Irony, PhD - statistical reviewer Review teamPrimary review team

  3. Angel Torres-Cabassa, CDRH Martin Yahiro, CDRH Sergio Gadaleta, CDRH Erin Keith, CDRH Kevin Lee, CDRH Tracey Bourke, CDRH Nirmal Mishra, CDRH Carol Arras, CDRH Mary Ann Wollerton, CDRH Pam Reynolds, CDRH Josie Yang, CDER Mercedes Serabian, CBER Barbara Wilcox, CBER John Hill, CBER Gary Kikuchi, CBER Carol Rehkopf, CBER Review teamAdditional review expertise

  4. Device description • InFUSE Bone Graft/LT-Cage Lumbar Tapered Fusion Device • 3 component spinal fusion device • spinal implant • growth factor • carrier

  5. Device description • InFUSE Bone Graft/LT-Cage Lumbar Tapered Fusion Device • component 1 • LT-Cage Lumbar Tapered Fusion Device • Ti alloy tapered spinal fusion cage • PMA approved for use with autograft to treat ddd

  6. Device description • InFUSE Bone Graft/LT-Cage Lumbar Tapered Fusion Device • components 2 and 3 • InFUSE Bone Graft consisting of: • rhBMP-2 • (recombinant human bone morphogenetic protein 2) • ACS • (absorbable collagen sponge)

  7. Data review • Preclinical • description of fusion cage • component unchanged from approved device • no additional review necessary • description of BMP and carrier • focus on issues related to FDA questions

  8. Data review • Clinical and statistical • discussion and analysis of clinical and radiographic outcomes • focus on issues related to FDA questions

  9. Panel questions • Reproduction and teratogenicity • Tumorogenicity • Radiographic effectiveness • Instructions for use • Postmarket studies

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