510(k) Report

Devices descending from K200074

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

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