Food and Drug Administration
Orthopedics and Rehabilitation Devices Advisory Panel
January 10, 2002
Briefing Information
P000058 InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device
Letter to Panel Members pdf
Overview Memo of the Entire PMA pdf
Preclinical Issues Summary pdf
Medtronic Sofamor Danek
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.
Cover Letter pdf
II.A. Open Surgical Approach Arm pdf
II.A. Tables pdf
II.B. Laparoscopic Surgical Approach Arm pdf
II.B. Tables pdf