510(k) K241769

Response Ortho Metaphyseal Hinge Fixator System by Response Ortho Solutions, LLC — Product Code KTT

K241769 is an FDA 510(k) premarket notification submitted by Response Ortho Solutions, LLC for the device "Response Ortho Metaphyseal Hinge Fixator System". The FDA issued a decision of Substantially Equivalent on September 18, 2024. 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 at least 1 other 510(k) clearance on record.