510(k) K942891

SUMMIT TOTAL HIP SYSTEM by Kirschner Medical Corp. — Product Code MEH

K942891 is an FDA 510(k) premarket notification submitted by Kirschner Medical Corp. for the device "SUMMIT TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on November 2, 1994. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Kirschner Medical Corp. has at least 10 other 510(k) clearances on record.