510(k) K223342

MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System by Crossroads Extremity Systems, LLC — Product Code HRS

K223342 is an FDA 510(k) premarket notification submitted by Crossroads Extremity Systems, LLC for the device "MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System". The FDA issued a decision of Substantially Equivalent on March 30, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Crossroads Extremity Systems, LLC has at least 10 other 510(k) clearances on record.