510(k) K181630

Revolution External Plating System by New Standard Device Dba Metalogix — Product Code KTT

K181630 is an FDA 510(k) premarket notification submitted by New Standard Device Dba Metalogix for the device "Revolution External Plating System". The FDA issued a decision of Substantially Equivalent on May 29, 2019. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. New Standard Device Dba Metalogix has at least 1 other 510(k) clearance on record.