510(k) K883212

LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT by Implant Technology, Inc. — Product Code KXA

K883212 is an FDA 510(k) premarket notification submitted by Implant Technology, Inc. for the device "LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT". The FDA issued a decision of Substantially Equivalent on November 22, 1988. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Implant Technology, Inc. has at least 10 other 510(k) clearances on record.