BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB)

BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB) is an FDA 510(k)-cleared medical device (K934515) manufactured by Zimmer, 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, 1995. Regulation: 8.