510(k) K983502

OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM by Osteonics Corp. — Product Code LPH

K983502 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 16, 1998. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Osteonics Corp. has at least 10 other 510(k) clearances on record.