510(k) K983141

CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS by Johnson & Johnson Professionals, Inc. — Product Code JDB

K983141 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS". The FDA issued a decision of Substantially Equivalent on November 6, 1998. The device falls under product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented), a Class II device regulated under 21 CFR 888.3160. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.