J-FX CERCLAGE SYSTEM

J-FX CERCLAGE SYSTEM is an FDA 510(k)-cleared medical device (K971682) manufactured by Johnson & Johnson Professionals, 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 June 26, 1997. Regulation: 8.