510(k) Report

Devices descending from K100373

4 later devices reach Tyche Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+2K143110GALAXY MIS Screw SystemBm Korea20152—
+3K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—