510(k) K223153

Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology by Medtronic Sofamor Danek USA, Inc. — Product Code MAX

K223153 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek USA, Inc. for the device "Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology". The FDA issued a decision of Substantially Equivalent on December 16, 2022. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Medtronic Sofamor Danek USA, Inc. has at least 10 other 510(k) clearances on record.