510(k) K934694

KIRSCHNER ZIRCONIA FEMORAL HEAD by Kirschner Medical Corp. — Product Code LZO

K934694 is an FDA 510(k) premarket notification submitted by Kirschner Medical Corp. for the device "KIRSCHNER ZIRCONIA FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on May 18, 1994. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Kirschner Medical Corp. has at least 10 other 510(k) clearances on record.