510(k) Report

Devices descending from K123347

2 later devices reach Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+1K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—