510(k) Report

Devices descending from K172269

4 later devices reach FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO®… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+1K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—