510(k) K896648

CONCEPT UNICOMPARTMENTAL KNEE SYSTEM by Concept, Inc. — Product Code HSX

K896648 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "CONCEPT UNICOMPARTMENTAL KNEE SYSTEM". The FDA issued a decision of SN on June 5, 1990. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Concept, Inc. has at least 10 other 510(k) clearances on record.