510(k) K232259

Patriot-SI Posterior Implant System by Spinal Simplicity, LLC — Product Code OUR

K232259 is an FDA 510(k) premarket notification submitted by Spinal Simplicity, LLC for the device "Patriot-SI Posterior Implant System". The FDA issued a decision of Substantially Equivalent on April 19, 2024. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Spinal Simplicity, LLC has at least 10 other 510(k) clearances on record.