510(k) K122382

DYNASTY BIOFOAM SHELL by Wrightmedicaltechnologyinc — Product Code MBL

K122382 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "DYNASTY BIOFOAM SHELL". The FDA issued a decision of Substantially Equivalent on October 22, 2012. The device falls under product code MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous), a Class II device regulated under 21 CFR 888.3358. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.