510(k) K211742

SignaSure Dual Mobility System by Signature Orthopaedics Pty, Ltd. — Product Code MEH

K211742 is an FDA 510(k) premarket notification submitted by Signature Orthopaedics Pty, Ltd. for the device "SignaSure Dual Mobility System". The FDA issued a decision of Substantially Equivalent on January 7, 2022. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Signature Orthopaedics Pty, Ltd. has at least 10 other 510(k) clearances on record.