510(k) Report

Devices descending from K200518

2 later devices reach Pitkar External Fixation System - Rail Mechanism through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241357XT3 SystemBiodynamik, Inc.20251—
+2K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—