510(k) K203697

BC Reflex Uni Knee System by Bodycad Laboratories, Inc. — Product Code HSX

K203697 is an FDA 510(k) premarket notification submitted by Bodycad Laboratories, Inc. for the device "BC Reflex Uni Knee System". The FDA issued a decision of Substantially Equivalent on March 12, 2021. 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.