510(k) Report

Devices descending from K182201

4 later devices reach Stratum™ Foot Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+1K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+1K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+1K200785Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc.20200—