510(k) K193368

Smart Correction System by Wishbone Medical, Inc. — Product Code KTT

K193368 is an FDA 510(k) premarket notification submitted by Wishbone Medical, Inc. for the device "Smart Correction System". The FDA issued a decision of Substantially Equivalent on September 18, 2020. 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. Wishbone Medical, Inc. has at least 8 other 510(k) clearances on record.