510(k) K121601

SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE by Synthes USA — Product Code HRS

K121601 is an FDA 510(k) premarket notification submitted by Synthes USA for the device "SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE". The FDA issued a decision of Substantially Equivalent on July 6, 2012. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Synthes USA has at least 10 other 510(k) clearances on record.