510(k) K260385

aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system by Carlsmed, Inc. — Product Code MAX

K260385 is an FDA 510(k) premarket notification submitted by Carlsmed, Inc. for the device "aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system". The FDA issued a decision of Substantially Equivalent on May 9, 2026. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Carlsmed, Inc. has at least 10 other 510(k) clearances on record.