510(k) Report

Devices descending from K120353

3 later devices reach Synster Pedicle Screw System Synster Plus Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143110GALAXY MIS Screw SystemBm Korea20152—
+2K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+3K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—