KSEA FLIPPTACK

KSEA FLIPPTACK is an FDA 510(k)-cleared medical device (K982571) manufactured by KARL STORZ Endoscopy-America, 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 21, 1998. Regulation: 8.