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Arthritis

Artelon CMC-I Spacer cleared by FDA for thumb arthritis

Published in Medical Devices and Surgical Technology Week, October 24th, 2004

Artimplant, a biomaterials and orthobiologics company based in Gothenburg, Sweden, has received U.S. Food & Drug Administration (FDA) clearance through a 510(k) for its Artelon CMC-I Spacer.

"This is a major milestone for Artimplant. The North American market represents more than 50% of the world market. Hand surgeons in the U.S. are waiting to treat patients with our Spacer. This product has considerable potential, which was clearly shown at the American Society for the Surgery of the Hand meeting," said Tord Lendau, CEO of Artimplant.

"Another 90 days was added to the FDA review process, because further information was requested. Consequently, a...

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