510(k) K061384

LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM by Walter Lorenz Surgical, Inc. — Product Code HRS

K061384 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM". The FDA issued a decision of Substantially Equivalent on June 6, 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.