510(k) Report

Devices descending from K143110

2 later devices reach GALAXY MIS Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+2K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—