KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A

KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A is an FDA 510(k)-cleared medical device (K032212) manufactured by Kyphon, 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 September 14, 2003. Regulation: 8.