510(k) Report

Devices descending from K211616

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

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