510(k) K983382

OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM by Osteonics Corp. — Product Code MEH

K983382 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 11, 1998. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Osteonics Corp. has at least 10 other 510(k) clearances on record.