510(k) Report

Devices descending from K101484

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130431Compressyn BandDallen Medical, Inc.20134—
+2K133858Tensyn BandDallen Medical, Inc.20143—
+3K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+4K143092Tensyn PlugDallen Medical, Inc.20151—
+5K150359Tensyn PlugDallen Medical, Inc.20150—