510(k) K220199

AFFINITY Proximal Tibia System by Techfit Digital Surgery, Inc. — Product Code HRS

K220199 is an FDA 510(k) premarket notification submitted by Techfit Digital Surgery, Inc. for the device "AFFINITY Proximal Tibia System". The FDA issued a decision of Substantially Equivalent on March 21, 2022. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Techfit Digital Surgery, Inc. has at least 4 other 510(k) clearances on record.