510(k) K990203

OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS by Osteonics Corp. — Product Code MEH

K990203 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS". The FDA issued a decision of Substantially Equivalent on February 18, 1999. 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.