510(k) Report

Devices descending from K993074

7 later devices reach Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070178Aesculap Resorbable Pin, Model FR735Aesculap Implant System, Inc.20070—
+1K041288Modification to SmartpinLinvatec Biomaterials, Inc.20042—
+1K0319812.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd.20033—
+1K013546Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc.20014—
+1K0120001.5MM Bone Fixation KitBionx Implants, Ltd.20015—
+2K073311Osteotrans-OT PinTakiron Co., Ltd.20080—
+2K071616Arc Surgical Biotrak Pin SystemArc Surgical, LLC20070—