510(k) K214123

T-FIX® 3DSI Joint Fusion System by Cutting Edge Spine, LLC — Product Code OUR

K214123 is an FDA 510(k) premarket notification submitted by Cutting Edge Spine, LLC for the device "T-FIX® 3DSI Joint Fusion System". The FDA issued a decision of Substantially Equivalent on June 24, 2022. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Cutting Edge Spine, LLC has at least 10 other 510(k) clearances on record.