510(k) K191641

AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws by Industrias Medicas Sampedro S.A.S — Product Code HRS

K191641 is an FDA 510(k) premarket notification submitted by Industrias Medicas Sampedro S.A.S for the device "AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws". The FDA issued a decision of Substantially Equivalent on Sep 16, 2019. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Industrias Medicas Sampedro S.A.S has at least 1 other 510(k) clearance on record.