BIOMETRIC TOTAL HIP SYSTEM

BIOMETRIC TOTAL HIP SYSTEM is an FDA 510(k)-cleared medical device (K935012) manufactured by Osteo-Technology Intl., 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 March 6, 1994. Regulation: 8.