510(k) K191374

Revival Modular Hip Stem by Corin U.S.A. Limited — Product Code LZO

K191374 is an FDA 510(k) premarket notification submitted by Corin U.S.A. Limited for the device "Revival Modular Hip Stem". The FDA issued a decision of Substantially Equivalent on July 22, 2019. 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. Corin U.S.A. Limited has at least 10 other 510(k) clearances on record.