510(k) K070292

DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS by Zimmer GmbH — Product Code KXA

K070292 is an FDA 510(k) premarket notification submitted by Zimmer GmbH for the device "DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS". The FDA issued a decision of Substantially Equivalent on April 26, 2007. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Zimmer GmbH has at least 10 other 510(k) clearances on record.