510(k) Report

Devices descending from K981283

203 later devices reach Rogachefsky Distal Radius Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K200226RetroFixRetrofix Screws, LLC20200—
+8K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—