510(k) K061144

DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT by DePuy Orthopaedics, Inc. — Product Code MBB

K061144 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT". The FDA issued a decision of Substantially Equivalent on June 8, 2006. 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.