510(k) K061844

DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER by Wrightmedicaltechnologyinc — Product Code JDL

K061844 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER". The FDA issued a decision of Substantially Equivalent on December 6, 2006. The device falls under product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3320. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.