510(k) K030384

EVOLVE CERAMIC RADIAL HEAD IMPLANT by Wrightmedicaltechnologyinc — Product Code KWI

K030384 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "EVOLVE CERAMIC RADIAL HEAD IMPLANT". The FDA issued a decision of Substantially Equivalent on August 12, 2003. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.