510(k) Report

Devices descending from K180690

9 later devices reach Navigation Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+1K183381Navigation Enabled InstrumentsStryker20191—
+1K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+1K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+2K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+2K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+2K201006K2M Navigation InstrumentsK2m, Inc.20200—