510(k) K190704

Signature Ceramic Femoral Head by Signature Orthopaedics Pty, Ltd. — Product Code LZO

K190704 is an FDA 510(k) premarket notification submitted by Signature Orthopaedics Pty, Ltd. for the device "Signature Ceramic Femoral Head". The FDA issued a decision of Substantially Equivalent on Aug 28, 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. Signature Orthopaedics Pty, Ltd. has 43 other 510(k) clearances on record.