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Food and Drug Administration

Orthopedic Devices Panel

 November 14, 2008

 FDA

Disclaimer

The statements contained in this document(s) are those of the product’s sponsor, not FDA and FDA does not necessarily agree with the sponsor’s statements.  FDA has not made a final determination about the safety or effectiveness of the product described in this document.

FDA Executive Summary, Questions and Summary

Sponsor

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552).  These redacted portions will appear as white spaces on the screen or on the printed page.

2008-4400b1-01- Intro K802079
2008-4400b1-02 – Appendix A
2008-4400b1-03- Appendix B
2008-4400b1-04-Appendix C
2008-4400b1-05- Appendix D
2008-4400b1-06-Appendix E  
2008-4400b1-07-Appendix F
2008-4400b1-08-Appendix G
2008-4400b1-09-Appendix H
2008-4400b1-10-Appendix I
2008-4400b1-11-Appendix J
2008-4400b1-12-Appendix K
2008-4400b1-13-L1-Appendix L1
2008-4400b1-14-Appendix L3
2008-4400b1-15-Appendix L2
2008-4400b1-16-Appendix M
2008-4400b1-17-Appendix N
2008-4400b1-18 Appendix O
2008-4400b1-19-Appendix P
2008-4400b1-20-Appendix Q
2008-4400b1-21-Appendix-A001
2008-4400b1-22-Appendix-A002
2008-4400b1-23-Appendix-A003
2008-4400b1-24-Appendix-B001
2008-4400b1-25-Appendix-B002
2008-4400b1-26-Appendix-B003
2008-4400b1-27-Appendix-C002
2008-4400b1-28-Appendix-C
2008-4400b1-29-Appendix-D002
2008-4400b1-30 Sponsors Panel summary
2008-4400b1-31 CMI Subjects

 


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