
Global Orthopaedic Technology, USA, Inc.
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GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE is an FDA 510(k)-cleared medical device (K033351) manufactured by Global Orthopaedic Technology, USA, 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 10, 2004. Regulation: 8.