510(k) Report

Devices descending from K180337

6 later devices reach EUROPA Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+1K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+1K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+1K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+2K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—