New Ionbond coating center in Switzerland for coating implant devices
New Ionbond Switzerland received Premarket Approval (PMA) and Premarket Notification (510(k)) by FDA
Our Coating Center in Switzerland, Dulliken
PACVD, PVD-Arc/Sputtering/HIPIMS technologies are offered in the newly refurbished IHI Ionbond coating center in Dulliken, Switzerland. The Dulliken site holds ISO 9001, ISO 14001 and ISO 13485 certifications. More than 15 years of experience in coating medical devices, fully validated processes and machinery, as well as state-of-the-art coating and analysis technologies serve the growing demand of medical coatings.
“Applying coating on orthopedic and spine implants requires a properly validated coating design and controlled process flow performed in an adequate environment. This is the case at Ionbond facilities in Switzerland, the USA and China, allowing us to develop the market in these three regions”
Dr. Ton Hurkmans
CTO
Ionbond Switzerland has coated for many years the 7 layer coating for Aesculap. Recently Medthin™ 42 and Medthin™ 01 were approved by FDA through PMA and 510(k), respectively.
Medthin™ 42 DLC and Medthin™ 43 ADLC are applied on award winning spine devices. Medthin™ 42 coated devices were evaluated by FDA to demonstrate the safety and probable clinical benefits of the less invasive, non-fusion deformity spine correction system.
“In recent years we have collected results from clinical trials and many simulator tests from coated devices - such data allows us to design adequate coatings to reduce wear and ion release, and thus substantially increase the probability for patients to avoid inflammatory processes over the short, medium and long term”, said Dr. Susann Schmidt, Segment Engineer for Medical applications.
Questions?
Discuss your challenges with Dr. Ing. Tobias Brögelmann
Tobias Brögelmann, Global Segment Manager Medical, will be glad to support you.
We will get back to you as soon as possible
Dr. Ing. Tobias Brögelmann
Global Segment Manager Medical
Dr. Ing. Tobias Brögelmann
Global Segment Manager Medical
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