510(k) Report

Devices descending from K210912

10 later devices reach Excelsius3D through their predicates, nearest generation first.

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