510(k) K000683

MODIFIED SINGLE AXLE TOTAL ELBOW by Biomet, Inc. — Product Code JDC

K000683 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "MODIFIED SINGLE AXLE TOTAL ELBOW". The FDA issued a decision of Substantially Equivalent on June 27, 2000. The device falls under product code JDC (Prosthesis, Elbow, Constrained, Cemented), a Class II device regulated under 21 CFR 888.3150. Biomet, Inc. has at least 10 other 510(k) clearances on record.