Advisory Committees
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2012 Meeting Materials of the Orthopaedic and Rehabilitation Devices Panel
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September 21, 2012: Meeting Materials FDA Generated
Agenda. (PDF - 35KB)Panel Roster (PDF - 28KB)Panel Questions (PDF - 82KB)FDA Executive Summary. (PDF - 484KB)Articles. (PDF - 7KB)- Appendix A: OSMA Petition Cover Letter (PDF - 685KB)
- Appendix A: OSMA Petition (PDF - 1.5MB)
Appendix B - Pediatric Data Abstraction Tables (PDF - 85KB)24-Hour Summary (PDF - 83KB)Presentation: FDA (PDF - 1.7MB)Transcript: Sept. 21. 2012 (PDF - 738KB)
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September 21, 2012: Meeting Materials Non-FDA Generated
OSMA Executive Summary Cover Letter (PDF - 94KB)OSMA Executive Summary (PDF - 551KB)Abstracts Design-Effectiveness (PDF - 335KB)Abstracts Safety (PDF - 217KB)Close‐up of Hooks and Screws (PDF - 46KB)Close‐up of Hooks and Screws: Larger photo (PDF - 280KB)OCT Construct X-rays (PDF - 268KB)Journals and Articles (PDF - 7KB)- C2 Pedicle Screw Insertion
Lateral Mass Screw Insertion
- Presentation: OSMA (PDF - 7MB)
- Presentation: Scoliosis Research Society (PDF - 2.8MB)
Presentation: American Academy of Orthopadic (PDF - 953KB)Presentation: North American Spine Society (PDF - 665KB)Presentation: Cervical Spine Research Society (PDF - 189KB)
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June 27-28, 2012: Meeting Materials FDA Generated
Public Agenda Day 1: June 27, 2012 (PDF - 35KB)Public Agenda Day 2: June 28, 2012 (PDF - 35KB)Panel Roster Day 1: June 27, 2012 (PDF - 26KB)Panel Roster Day 2: June 28, 2012 (PDF - 29KB)FDA Executive Summary (PDF - 2.5MB)Draft Panel Questions (PDF - 117KB)Appendix A (PDF - 165KB)Appendix B (PDF - 553KB)Appendix C (PDF - 43KB)Appendix D (PDF - 43KB)Appendix F (PDF - 1KB)Appendix G (PDF - 56KB)Appendix H (PDF - 1KB)Appendix I (PDF - 630KB)Appendix J (PDF - 2MB)Appendix K (PDF - 1KB)Appendix L (PDF - 1KB)Appendix M (PDF - 12KB)Appendix N (PDF - 1KB)Appendix O (PDF - 1KB)June 27, 2012 Meeting Presentations June 28, 2012 Meeting Presentations - 24-Hour Summary Day 1 - June 27, 2012 (PDF - 126KB)
24-Hour Summary Day 2 - June 28, 2012 (PDF - 96KB)Transcript: June 27, 2012 (PDF - 1.3MB)Transcript: June 28, 2012 (PDF - 1.5MB)
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