ACE UNILATERAL FIXATOR II

ACE UNILATERAL FIXATOR II is an FDA 510(k)-cleared medical device (K936045) manufactured by Ace Orthopedic Manufacturing Co.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 21, 1994. Regulation: 8.