510(k) K170339

Summit Hip System by DePuy Orthopaedics, Inc. — Product Code LZO

K170339 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "Summit Hip System". The FDA issued a decision of Substantially Equivalent on April 26, 2018. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.