510(k) K081163

SMARTSET GMV GENTAMICIN BONE CEMENT by DePuy Orthopaedics, Inc. — Product Code MBB

K081163 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "SMARTSET GMV GENTAMICIN BONE CEMENT". The FDA issued a decision of Substantially Equivalent on May 14, 2008. The device falls under product code MBB (Bone Cement, Antibiotic), a Class II device regulated under 21 CFR 888.3027. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.