510(k) Report

Devices descending from K243635

5 later devices reach aprevo® anterior lumbar interbody fusion device with interfixation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+1K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+2K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+3K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+3K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—