Subject: FDA
NGMedical GmbH Receives FDA Clearance for Its AM Titanium Cervical Interbody BEE®
SCOTTSDALE, Ariz., Feb. 3, 2021 /PRNewswire/ -- NGMedical, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application, announces FDA clearance for its purely additively manufactured titanium cervical BEE® cage.
The BEE® cage is designed to challenge the limits of additive manufacturing. The purposefully designed honeycomb endplate design reduces the risk of subsidence while allowing fusion. The honeycomb structure allows for bony ingrowth and demonstrates the reduced use of titanium minimizing risks of X-ray artefacts, while offering a very large graft space. This is another significant innovation from the team, who invented the first line of additively manufactured interbody devices.
"This is an important step for NGMedical and allows us to start our active market presence in the USA. We are proud having received the FDA clearance based on the innovative design introduced to the OUS market in 2020. Our team did a great job in cooperation with MRC Global," says Nino Weiland, Operations Manager of NGMedical.
"The approval of the BEE cage is a remarkable accomplishment as it provides maximum surface area due to the honeycomb structure and laterally accessed lumen. This implant, along with its streamlined and elegant instrumentation, is perfectly suited for the U.S. surgeon as it addresses every key metric including: anatomical design for bony fusion, maximum porosity with improved imaging and increased surface area minimizing subsidence," according to Josh Sandberg of NGMedical, Inc.
"NGMedical is a hard-working, innovative team that worked diligently to ensure all necessary data was provided to support clearance through FDA for the BEE® AM Cage," says Christine Scifert of MRC Global.
NGMedical, Inc. is actively seeking qualified representation nationwide. If interested in learning more, please call us at (480) 609-4864.
About NGMedical
We are an owner-managed company specializing in the development of innovative spinal implants. Many years of experience, combined with a high degree of creativity, give us the impetus to significantly advance the development of spine surgery.
The NGMedical team has been developing innovative product systems since 2001. NGMedical derived out of the company Advanced Medical Technologies AG, which was acquired by Medtronic Inc. in 2012. NGMedical exploits this longtime experience combined with a high degree of creativity and know-how for the development of further innovative product concepts. Both, earlier and today, the cooperation with a team of experienced surgeons and scientists is the basis for the market-driven orientation. Many product solutions, today accepted and widely used as standards, derive from our team.
Contact:
Josh Sandberg
480-609-4864
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