510(k) K113019

PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER by Wrightmedicaltechnologyinc — Product Code KWA

K113019 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER". The FDA issued a decision of Substantially Equivalent on November 10, 2011. The device falls under product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3330. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.