510(k) K170089

U-Motion II Acetabular System— Additional sizes by United Orthopedic Corporation — Product Code LZO

K170089 is an FDA 510(k) premarket notification submitted by United Orthopedic Corporation for the device "U-Motion II Acetabular System— Additional sizes". The FDA issued a decision of Substantially Equivalent on October 6, 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. United Orthopedic Corporation has at least 10 other 510(k) clearances on record.