510(k) Report

Devices descending from K172886

4 later devices reach Breakaway Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+2K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+2K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—