510(k) K053189

COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES by Zimmer, Inc. — Product Code JDC

K053189 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES". The FDA issued a decision of Substantially Equivalent on December 9, 2005. The device falls under product code JDC (Prosthesis, Elbow, Constrained, Cemented), a Class II device regulated under 21 CFR 888.3150. Zimmer, Inc. has at least 10 other 510(k) clearances on record.