510(k) Report

Devices descending from K201457

2 later devices reach Auxein Brand Vertaux 5.5 mm Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+1K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—