510(k) K935206

KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION by Kirschner Medical Corp. — Product Code JDI

K935206 is an FDA 510(k) premarket notification submitted by Kirschner Medical Corp. for the device "KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION". The FDA issued a decision of Substantially Equivalent on Jul 13, 1994. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Kirschner Medical Corp. has at least 10 other 510(k) clearances on record.