510(k) K233017

TM Plating System by Tyber Medical, LLC — Product Code HRS

K233017 is an FDA 510(k) premarket notification submitted by Tyber Medical, LLC for the device "TM Plating System". The FDA issued a decision of Substantially Equivalent on December 20, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Tyber Medical, LLC has at least 10 other 510(k) clearances on record.