510(k) K972691

ABC TOTAL ELBOW PROTHESIS by Biomet, Inc. — Product Code JDB

K972691 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "ABC TOTAL ELBOW PROTHESIS". The FDA issued a decision of Substantially Equivalent on October 15, 1997. The device falls under product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented), a Class II device regulated under 21 CFR 888.3160. Biomet, Inc. has at least 10 other 510(k) clearances on record.