510(k) K233816

REDEMPTION Charcot Plating System by Vilex, LLC — Product Code HRS

K233816 is an FDA 510(k) premarket notification submitted by Vilex, LLC for the device "REDEMPTION Charcot Plating System". The FDA issued a decision of Substantially Equivalent on August 28, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Vilex, LLC has at least 10 other 510(k) clearances on record.