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