510(k) Report

Devices descending from K242516

2 later devices reach EUROPA™ Posterior Cervical Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+2K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—