510(k) K052079

PINNACLE CONSTRAINED ACETABULAR LINERS by DePuy Orthopaedics, Inc. — Product Code KWZ

K052079 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "PINNACLE CONSTRAINED ACETABULAR LINERS". The FDA issued a decision of Substantially Equivalent on October 21, 2005. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.