510(k) Report

Devices descending from K042508

301 later devices reach Sumit Oct Spinal System and Mountaineer Oct Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—