510(k) K023718

QUICKSET MIMIX BONE VOID FILLER by Walter Lorenz Surgical, Inc. — Product Code GXP

K023718 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "QUICKSET MIMIX BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on December 4, 2002. The device falls under product code GXP (Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.