510(k) K063857

SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT by Howmedica Osteonics Corp. — Product Code MBB

K063857 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT". The FDA issued a decision of Substantially Equivalent on February 26, 2007. The device falls under product code MBB (Bone Cement, Antibiotic), a Class II device regulated under 21 CFR 888.3027. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.