POLYBONE GRANULE & BLOCK

POLYBONE GRANULE & BLOCK is an FDA 510(k)-cleared medical device (K082338) manufactured by Kyung Won Medical 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 October 15, 2008. Regulation: 8.