510(k) K173491

RTS Lesser MTP Implant System by In2bones USA, LLC — Product Code KWH

K173491 is an FDA 510(k) premarket notification submitted by In2bones USA, LLC for the device "RTS Lesser MTP Implant System". The FDA issued a decision of Substantially Equivalent on February 23, 2018. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. In2bones USA, LLC has at least 10 other 510(k) clearances on record.