510(k) Report

Devices descending from K190092

13 later devices reach UNiD Patient specific 3D printed TLIF cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+2K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+2K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+3K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+3K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+3K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+3K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+3K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—