510(k) Report

Devices descending from K043059

207 later devices reach Compression Staple and Simple Staple through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K143092Tensyn PlugDallen Medical, Inc.20151—
+9K252246Leforte MMF SystemJeil Medical Corporation20260—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+9K150359Tensyn PlugDallen Medical, Inc.20150—