510(k) Report

Devices descending from K182158

21 later devices reach UNiD Patient-matched PLIF cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+1K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+1K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+2K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+2K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+2K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+2K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+2K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+3K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+3K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+3K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+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—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—