510(k) K210534

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System by Gramercy Extremity Orthopedics, LLC — Product Code HRS

K210534 is an FDA 510(k) premarket notification submitted by Gramercy Extremity Orthopedics, LLC for the device "GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System". The FDA issued a decision of Substantially Equivalent on March 26, 2021. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Gramercy Extremity Orthopedics, LLC has at least 4 other 510(k) clearances on record.