510(k) K063506

LORENZ STERNAL CLOSURE SYSTEM by Walter Lorenz Surgical, Inc. — Product Code HRS

K063506 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "LORENZ STERNAL CLOSURE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 18, 2006. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.