510(k) K060988

TOTAL AND HEMI SHOULDER SYSTEM by Dvo Extremity Solutions, LLC — Product Code KWS

K060988 is an FDA 510(k) premarket notification submitted by Dvo Extremity Solutions, LLC for the device "TOTAL AND HEMI SHOULDER SYSTEM". The FDA issued a decision of Substantially Equivalent on December 6, 2006. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Dvo Extremity Solutions, LLC has at least 3 other 510(k) clearances on record.