OSSEOFLEX SB INFLATABLE BONE TAMP

OSSEOFLEX SB INFLATABLE BONE TAMP is an FDA 510(k)-cleared medical device (K122533) manufactured by Osseon Therapeutics, Inc.. 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 22, 2012. Regulation: 8.