510(k) Report

Devices descending from K211496

7 later devices reach TransLoc 3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+1K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+2K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—