510(k) K190595

Signature ONE System by Orthosoft Inc (D/B/A Zimmer Cas) — Product Code KWT

K190595 is an FDA 510(k) premarket notification submitted by Orthosoft Inc (D/B/A Zimmer Cas) for the device "Signature ONE System". The FDA issued a decision of Substantially Equivalent on June 5, 2019. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Orthosoft Inc (D/B/A Zimmer Cas) has at least 10 other 510(k) clearances on record.