510(k) Report

Devices descending from K190498

7 later devices reach Fortilink® IBF System with TETRAfuse®3D Technology, include the following… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+1K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+2K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—