510(k) Report

Devices descending from K151000

15 later devices reach O-Arm O2 Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173664Medtronic O-arm O2 Imaging SystemMedtronic, Inc.2017142
+2K200074O-arm O2 Imaging SystemMedtronic, Inc.202013—
+3K240465O-arm O2 Imaging SystemMedtronic Navigation, Inc.202402
+3K221230TRONXoran Technologies, LLC20220—
+3K210912Excelsius3DGlobus Medical, Inc.202110—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—