510(k) K960087

SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) by Wrightmedicaltechnologyinc — Product Code JDB

K960087 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)". The FDA issued a decision of Substantially Equivalent on September 20, 1996. The device falls under product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented), a Class II device regulated under 21 CFR 888.3160. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.