Food and Drug Administration

Orthopedic and Rehabilitation Devices Panel

January 10, 2002

Tentative Slides

P000058 InFUSE™ Bone Graft, LT-CAGE™ Lumbar Tapered Device

Introduction, FDA   ppt   htm

Statistical Analysis rhBMP-2/ACS InFUSE Device, Telba Irony, PhD, FDA   ppt   htm

Sofamor Preclinical - Peter L Hudson, PhD, FDA   ppt   htm

Introduction, Bailey Lipscomb, PhD, Medtronic Sofamor Danek   ppt   htm

Clinical Review, Barbara Buch, MD   ppt   htm

Concluding Remarks, Bailey Lipscomb, PhD, Medtronic Sofamor Danek   ppt   htm

Summary of InFUSE™ Bone Graft Preclinical and Pilot Clinical Studies with Interbody Spinal Fusion Devices, Scot Boden, MD, The Emory Spine Center, Emory University School of Medicine   ppt   htm

InFUSE™  Bone Graft / LT-CAGE™ Lumbar Tapered Fusion Device, IDE Clinical Results, G960065, Hallett H Mathews, MD   ppt   htm

rhBMP-2: Origin, Biology and Preclinical Safety, Gerard E Riedel PhD, Wyeth-Genetics Institute, Inc   ppt  htm

Panel Questions   ppt   htm