Codman 46-2010 MedFix Surgical 11″ Curved Osteotome 6mm Tip Spinal Orthopedics The sale of this item may be subject by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item. Any used product has been cleaned/sterilized per manufacturers specifications.