510(k) Report

Devices descending from K180539

4 later devices reach Deformity Analysis and Correction Software (DACS) and Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+2K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+2K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+2K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—