GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM

GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM is an FDA 510(k)-cleared medical device (K983814) manufactured by Efratgo, Ltd. HI Tech Bio-Surgical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 13, 1999. Regulation: 8.