510(k) K073499

VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES by Zimmer, Inc. — Product Code JDL

K073499 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES". The FDA issued a decision of Substantially Equivalent on August 7, 2008. 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. Zimmer, Inc. has at least 10 other 510(k) clearances on record.