510(k) K212297

Omni Foot and Ankle Plating System by Extremity Medical, LLC — Product Code HRS

K212297 is an FDA 510(k) premarket notification submitted by Extremity Medical, LLC for the device "Omni Foot and Ankle Plating System". The FDA issued a decision of Substantially Equivalent on August 20, 2021. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Extremity Medical, LLC has at least 10 other 510(k) clearances on record.