TGM Biolox delta Ceramic Heads

TGM Biolox delta Ceramic Heads is an FDA 510(k)-cleared medical device (K150576) manufactured by Tgm Medical, 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 September 8, 2015. Regulation: 8.