The first implantable medical device using Invibio®'s carbon fiber-reinforced (CFR) PEEK-OPTIMA® compound has received regulatory approval from the Japanese Ministry of Health, Labour and Welfare, the governing body responsible for regulating all drugs and medical devices in Japan.
This is represents the second regulatory approval of an orthopedic device using Invibio implantable biomaterials granted in Japan. The first was for an arthroscopy device using unfilled PEEK-OPTIMA polymer that was approved in Japan in 2005 and has been commercially available for more than 18 months.
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