510(k) K011819

RADIAL HEAD IMPLANT by Avanta Orthopaedics, Inc. — Product Code KWI

K011819 is an FDA 510(k) premarket notification submitted by Avanta Orthopaedics, Inc. for the device "RADIAL HEAD IMPLANT". The FDA issued a decision of Substantially Equivalent on June 19, 2001. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. Avanta Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.