RegulatorySpine

Tsunami Medical announces CE-mark for Second Generation of Spinal Fusion Solutions

Modena, May 17th 2021

Tsunami Medical, one of the leaders in Spine Technology innovation, focusing on additive manufactured solutions for spine surgery and diagnostic invasive procedures, today announces the achievement of the CE-mark for the Second Generation of Spinal Fusion products.

Years of cautious research and dedication by Tsunami Medical’s team, have culminated with the conquest of this necessary regulatory certification. The Second Generation of innovative, differentiating and unique products is an addition to the First Generation of Fusion Solutions: a line of intervertebral cages based on successfully proven Bone InGrowth Technology® with options for all surgical approaches.

“With four cages with built-in additional fixation features, four expandable ones and the first 3D-printed screw and rod system in the world, both for open and MIS procedures, we now are offering a full product portfolio for Spinal Fusion”, said Stefano Caselli, CEO of the company and also responsible for product design and development.

Peter Witke, a veteran in international sales and business development, CCO of the company: “I feel excited about representing the company with now the largest offering of additive manufactured solutions for Spinal Fusion in the world! We will gradually launch this wave of innovation in the upcoming months, stay tuned”.

Stefano Caselli concludes: “We consider this a milestone in the company’s business and future growth potential and I kindly invite others in the international markets to benefit locally from this; please feel free to contact our CCO: peter.witke@tsunamimed.com”.

About the Company

Tsunami Medical was founded in 1997, manufacturing invasive diagnostic devices as subcontractor of big manufacturing companies. Over the years the Company has bought the Bloodline trademark, very well known in the international biopsy and vertebroplasty spinal markets.

 In 2010 Tsunami Medical started the design and manufacturing of Selective Laser Melting (SLM) technology, resulting in the currently available implant product portfolio.

Located in the heart of the “Biomedical Valley”, nearby Modena (Italy), the manufacturing facility extends on 1200 square meters with modern machinery and clean rooms class ISO 8, 13485 certified to design and manufacture medical devices.

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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