510(k) Report

Devices descending from K131850

5 later devices reach Tensyn Band through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+1K143092Tensyn PlugDallen Medical, Inc.20151—
+1K133858Tensyn BandDallen Medical, Inc.20143—
+2K150359Tensyn PlugDallen Medical, Inc.20150—
+2K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—