510(k) K231923

Liberty SI Lateral Implant System by Spinal Simplicity, LLC — Product Code OUR

K231923 is an FDA 510(k) premarket notification submitted by Spinal Simplicity, LLC for the device "Liberty SI Lateral Implant System". The FDA issued a decision of Substantially Equivalent on December 5, 2023. 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.