510(k) K070267

DEPUY GCK TIBIAL COMPONENTS by DePuy Orthopaedics, Inc. — Product Code HRY

K070267 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "DEPUY GCK TIBIAL COMPONENTS". The FDA issued a decision of Substantially Equivalent on August 17, 2007. 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. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.