510(k) K122853

NOVEL FIT AND FILL STEM by Howmedica Osteonics Corp. — Product Code MEH

K122853 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "NOVEL FIT AND FILL STEM". The FDA issued a decision of Substantially Equivalent on February 1, 2013. 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. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.