510(k) K070731

PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM by Plus Orthopedics AG — Product Code HAW

K070731 is an FDA 510(k) premarket notification submitted by Plus Orthopedics AG for the device "PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM". The FDA issued a decision of Substantially Equivalent on July 31, 2007. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Plus Orthopedics AG has at least 10 other 510(k) clearances on record.