
Solco Biomedical Co., Ltd.
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THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM is an FDA 510(k)-cleared medical device (K043578) 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 March 6, 2005. Regulation: 8.