510(k) K112030

SYNTHES RADIAL HEAD PROSTHESIS SYSTEM by Synthes USA, LLC — Product Code KWI

K112030 is an FDA 510(k) premarket notification submitted by Synthes USA, LLC for the device "SYNTHES RADIAL HEAD PROSTHESIS SYSTEM". The FDA issued a decision of Substantially Equivalent on June 19, 2012. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. Synthes USA, LLC has at least 10 other 510(k) clearances on record.