November 8, 2016
Artoss, Inc. is pleased to announce that, on October 26, 2016, Artoss GmbH received notice from the U.S. Food & Drug Administration that NanoBone® SBX Putty has been cleared to market as 510(k) K161351.
Walter Gerike, Managing Director of Artoss GmbH said, “Nanotechnology is the key technology for the 21st century and Artoss is harnessing this potential for orthopaedic surgery. In NanoBone SBX Putty, we have a product that combines Applied NanoBiology™ for bone repair with perfect handling for the surgeon.” NanoBone synthetic bone graft products have been used in Europe for ten years in approaching 400,000 clinical cases across all indications.
James J. Cassidy, Ph.D., Managing Director of Artoss, Inc., the exclusive North American distributors for NanoBone in orthopaedic surgery, stated, “NanoBone technology has been in great demand by U.S. surgeons since we launched NanoBone Granules in 2015. NanoBone SBX Putty offers the same clinical performance in an easier to use presentation. We look forward to introducing this product in a variety of sizes to the U.S. market in the coming weeks.”
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