510(k) K222082

aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices by Carlsmed, Inc. — Product Code MAX

K222082 is an FDA 510(k) premarket notification submitted by Carlsmed, Inc. for the device "aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices". The FDA issued a decision of Substantially Equivalent on August 12, 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. Carlsmed, Inc. has at least 10 other 510(k) clearances on record.