Food and Drug Administration

ORTHOPAEDIC AND REHABILITATION DEVICES PANEL
of the
MEDICAL DEVICES ADVISORY COMMITTEE

July 15, 2008

SLIDES

FDA Presentations:

FDA Presentation (pdf)
      Presented by:

• Jismi Jose, Biomedical Engineer, Orthopedic Spine Devices Branch, Division of General, Restorative, and Neurological Devices, Office of Device Evaluation

• Kevin Lee, M.D., Medical Officer, Orthopedic Joint Devices Branch, Division of General, Restorative, and Neurological Devices, Office of Device Evaluation
• Jack Zhou, M.S., Division of Biostatistics, Office of Surveillance and Biometrics
• Jiping Chen, M.D., Ph.D. , Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics

FDA Panel Questions (pdf)
            Presented by:

• Jismi Jose, Biomedical Engineer, Orthopedic Spine Devices Branch, Division of General, Restorative, and Neurological Devices, Office of Device Evaluation

Sponsor Presentations:

Sponsor Presentation (pdf)
      Presented by:

• John Krelle, President and CEO, FzioMed, Inc.
• Alfred Rhyne, M.D., OrthoCarolina Spine Center, Charlotte, NC
• Gere diZerega, M.D., Medical Director, FzioMed, Inc.
• Ronald Ehmsen, Sc.D., Vice President of Clinical & Regulatory Affairs, FzioMed, Inc.
• Paul Arnold, M.D., University of Kansas Medical Center, Kansas City, KS
• Richard Chiacchierini, Ph.D., R.P. Chiacchierini & Associates, LLC, Rockville, MD
• Scott Blumenthal, M.D., Texas Back Institute, Plano, TX

Written Comments

Written Comment 1 (pdf)
      Written by: Roberto Assietti, M.D., Fatebenefratelli Hospital, Milan, Italy

Written Comment 2 (pdf)
      Written by: Jim Youssef, M.D., Durango Orthopedics SpineColorado, Durango, CO

Written Comment 3 (pdf)
      Written by: Richard Guyer, M.D., Texas Back Institute, Plano, TX

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