KYPHON XPANDER II INFLATABLE BONE TAMP

KYPHON XPANDER II INFLATABLE BONE TAMP is an FDA 510(k)-cleared medical device (K101864) manufactured by Medtronic. 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 13, 2010. Regulation: 8.