510(k) Report

Devices descending from K190069

3 later devices reach SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+1K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+1K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—