510(k) K191150

Bodycad Unicompartmental Knee System by Bodycad Laboratories, Inc. — Product Code HSX

K191150 is an FDA 510(k) premarket notification submitted by Bodycad Laboratories, Inc. for the device "Bodycad Unicompartmental Knee System". The FDA issued a decision of Substantially Equivalent on October 8, 2019. 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. Bodycad Laboratories, Inc. has at least 10 other 510(k) clearances on record.