510(k) K231743

F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System by Corelink, LLC — Product Code MAX

K231743 is an FDA 510(k) premarket notification submitted by Corelink, LLC for the device "F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System". The FDA issued a decision of Substantially Equivalent on December 8, 2023. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Corelink, LLC has at least 10 other 510(k) clearances on record.