510(k) K263083

Response Ortho Smart Fixator - Hexapod System by Response Ortho Solutions, LLC — Product Code KTT

K263083 is an FDA 510(k) premarket notification submitted by Response Ortho Solutions, LLC for the device "Response Ortho Smart Fixator - Hexapod System". The FDA issued a decision of Substantially Equivalent on Oct 2, 2026. 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. Response Ortho Solutions, LLC has 2 other 510(k) clearances on record.