GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL

GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL is an FDA 510(k)-cleared medical device (K043233) 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 31, 2005. Regulation: 8.