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news.K2M, a spinal device company, has entered the international spine market via its recently acquired ISO 13485 certification and CE mark clearance for its spinal devices.
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The K2M product portfolio cleared for sale encompasses a full array of products developed to treat complex spinal conditions and includes the Range spinal system, Mesa spinal system, Denali spinal system, Pyrenees cervical plate system and Aleutian spacer systems, said K2M.
Similar to 510(k) approval in the US, the CE mark allows for sale and distribution of products for specific indications within Europe and other countries. K2M’s international expansion has started with the successful introduction of its products in Spain and the UK, according to K2M.
Eric Major, K2M’s president and CEO, said: “We are committed to expanding the availability of our innovative technology to countries around the world and supporting surgeons treating the most difficult spinal deformities. Our mission is to be the worldwide leader in providing solutions to complex spinal pathologies.”