
Solco Biomedical Co., Ltd.
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4CIS VANE SPINE SYSTEM is an FDA 510(k)-cleared medical device (K101818) manufactured by Solco Biomedical Co., Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 10, 2011. Regulation: 8.