510(k) K051385

EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE by Biomet, Inc. — Product Code KWI

K051385 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE". The FDA issued a decision of Substantially Equivalent on August 5, 2005. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. Biomet, Inc. has at least 10 other 510(k) clearances on record.