510(k) Report

Devices descending from K211957

3 later devices reach QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+2K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—