510(k) K063052

LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES by Walter Lorenz Surgical, Inc. — Product Code JEY

K063052 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES". The FDA issued a decision of Substantially Equivalent on January 12, 2007. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.