4CIS SOLAR AND APOLLON SPINE SYSTEMS

4CIS SOLAR AND APOLLON SPINE SYSTEMS is an FDA 510(k)-cleared medical device (K082453) 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 September 22, 2008. Regulation: 8.