510(k) K150730

Zimmer PSI Shoulder System by Zimmer — Product Code KWT

K150730 is an FDA 510(k) premarket notification submitted by Zimmer for the device "Zimmer PSI Shoulder System". The FDA issued a decision of Substantially Equivalent on June 16, 2015. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Zimmer has at least 10 other 510(k) clearances on record.