510(k) K050764

UNIGLIDE UNICONDYLAR KNEE PROSTHESIS by Corin USA — Product Code HRY

K050764 is an FDA 510(k) premarket notification submitted by Corin USA for the device "UNIGLIDE UNICONDYLAR KNEE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on August 24, 2005. The device falls under product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3530. Corin USA has at least 10 other 510(k) clearances on record.