MedShape Solutions has received CE mark approval for its Morphix Suture Anchor. As found on their website:
The CE Marking confirms that both medical devices comply with the essential requirements of relevant European health, safety, and environmental protection legislation, and have been subjected to conformity assessment procedures. Receipt of the CE Marking allows MedShape Solutions to market and sell the Morphix Anchor and the ExoShape Interference Fixation Device in the European Free Trade Association (EFTA) and the European Economic Area. The company has begun discussions with third party distributors across the region.
Morphix is a suture anchor manufactured from MedShape’s shape memory PEEK Altera biomedical polymer. The device received FDA 510(k) clearance in September 2009 and has been fully commercially launched in the U.S.
Find out more information about the Morhpix Bone Anchor on their product page.
No comments:
Post a Comment