510(k) K992462

OSTEONICS UNIVERSAL DISTAL CEMENT PLUG by Howmedica Osteonics Corp. — Product Code LZN

K992462 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "OSTEONICS UNIVERSAL DISTAL CEMENT PLUG". The FDA issued a decision of Substantially Equivalent on August 13, 1999. The device falls under product code LZN (Cement Obturator), a Class II device regulated under 21 CFR 878.3300. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.