510(k) K190834

Corin Optimized Position System Functional Hip Analysis (OPS FHA) by Corin USA — Product Code LZO

K190834 is an FDA 510(k) premarket notification submitted by Corin USA for the device "Corin Optimized Position System Functional Hip Analysis (OPS FHA)". 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 USA has at least 10 other 510(k) clearances on record.