InFUSE

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InFUSE Bone Graft /LT-CAGE Lumbar Tapered
Fusion DeviceConcluding Remarks

• Bailey Lipscomb, Ph.D.Medtronic Sofamor Danek

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• Have Demonstrated a Reasonable Assurance of
  Safety and Effectiveness

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FDA Questions to Panel

• Tumor Cell Proliferation

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FDA Questions to Panel

• Tumor Cell Proliferation
• rhBMP-2 Antibody Effects

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FDA Questions to Panel

• Tumor Cell Proliferation
• BMP-2 Antibody Effects on Fetus
• Radiological Assessment

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InFUSE Bone Graft /LT-CAGE Lumbar Tapered
Fusion Device

• SAFE AND EFFECTIVE

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Thank You