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FDA OKs Solco’s spinal fixation system

Lee Han-soo  Published 2019.08.13  14:41  Updated 2019.08.13 14:41

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Solco Biomedical, a local medical device company, said the U.S. Food and Drug Administration has approved its “4CIS Chiron Spinal Fixation System,” a product that fixes, supports and aligns the spine.

“Chiron system is designed to be applied to all spinal surgery methods such as mono, poly, poly cannul, reduction, minimal invasive surgery,” a company official said. “The product is designed and configured as a multifunction system to reflect the global trend of the latest spinal surgery.”

Notably, it is designed to prevent pull-out, a phenomenon where the fixing device detaches from the body after the operation, he added.

Solco Biomedical CEO Kim Il, also said, “The FDA-approved product has a big demand in the global market. As it is a competitive product, the company expects that it will increase sales for the company globally.”

The company plans to market the device simultaneously in Korea and the U.S. from next month.

corea022@docdocdoc.co.kr

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