510(k) K040990

MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS by Walter Lorenz Surgical, Inc. — Product Code NEU

K040990 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS". The FDA issued a decision of Substantially Equivalent on May 13, 2004. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.