510(k) K033351

GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE by Global Orthopaedic Technology, USA, Inc. — Product Code HRY

K033351 is an FDA 510(k) premarket notification submitted by Global Orthopaedic Technology, USA, Inc. for the device "GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE". The FDA issued a decision of Substantially Equivalent on March 11, 2004. The device falls under product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3530. Global Orthopaedic Technology, USA, Inc. has at least 2 other 510(k) clearances on record.