510(k) Report

Devices descending from K841189

2,425 later devices reach Oec/Rezaian Spinal Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+11K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+11K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+11K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+11K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+12K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+12K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+12K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+12K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+12K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+12K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+12K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+12K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+12K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+12K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+12K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+12K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+12K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+13K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+13K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+13K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+13K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+13K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+14K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+14K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—