510(k) K111663

TRAUMA INTERNAL FIXATION SYSTEMS by DePuy Orthopaedics, Inc. — Product Code HRS

K111663 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "TRAUMA INTERNAL FIXATION SYSTEMS". The FDA issued a decision of Substantially Equivalent on March 12, 2012. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.