510(k) Report

Devices descending from K013546

4 later devices reach Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0319812.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd.20033—
+2K041288Modification to SmartpinLinvatec Biomaterials, Inc.20042—
+3K073311Osteotrans-OT PinTakiron Co., Ltd.20080—
+3K071616Arc Surgical Biotrak Pin SystemArc Surgical, LLC20070—