510(k) K013557

LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW by Walter Lorenz Surgical, Inc. — Product Code MBI

K013557 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW". The FDA issued a decision of Substantially Equivalent on November 16, 2001. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.