
Ed. Geistlich Soehne AG Fur Chemische Industrie
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ORTHOSS is an FDA 510(k)-cleared medical device (K090401) manufactured by Ed. Geistlich Soehne AG Fur Chemische Industrie. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 7, 2010. Regulation: 8.