510(k) K161226

Revision Femoral Stem by Lima Corporate S.P.A. — Product Code LZO

K161226 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "Revision Femoral Stem". The FDA issued a decision of Substantially Equivalent on Feb 10, 2017. 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. Lima Corporate S.P.A. has 63 other 510(k) clearances on record.